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WEBINAR: Specifications for Small Molecule Drug Products
 
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Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry. This webinar will cover: • Regulatory guidance (ICH, FDA, EMA) • Tests appropriate to different dosage forms • Dissolution specifications for immediate-release, modified-release and extended-release drug products • Dissolution specifications in the context of the biopharmaceutical classification system • Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination • Specifications for combination drug products • The role of specifications in maximizing drug product stability
Introduction to ICH Guidelines
 
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The presentation is on Basic understanding to technical requirements as per ICH Guidelines (The International Conference on Harmonization)
Views: 21692 Biobridge Healthcare
Lifecycle Approach to API Process Validation
 
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The goal of API process validation is to ensure the reliable production of high-quality active pharmaceutical ingredients from development through commercialization. The product lifecycle approach established in FDA's 2011 Process Validation Guidance requires different validation activities during the process design and process qualification stages, as well as continued process verification throughout the life of the commercial process. The process validation needs for pre-qualification activities and ongoing process verification can be daunting, especially for small and medium-size pharmaceutical companies. In this webinar, experts on API process validation outline the key requirements for development of a phase appropriate manufacturing plan including regulatory requirements, data collection, specification development, critical process parameters, sampling plans, and analytical method validation. Key Learning Objectives: * Understand the regulatory expectations at each clinical phase. * Determine the key validation aspects of API manufacturing including critical process parameters. * Identify analytical and stability needs as the API advances in the clinic. Moderator: Rita Peters Editorial Director Pharmaceutical Technology Speakers: Paul Wrezel, Ph.D. Director of Analytical Method Development Regis Technologies Bikash Chatterjee President and Chief Technology Officer Pharmatech Associates Inc. Paul L. Pluta, PhD Editor-in-Chief Journal of GXP Compliance and Journal of Validation Technology
Views: 12327 Regis Technologies Inc
Raw Material Qualification Process
 
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http://www.integrativepro.com/quality At Integrative Therapeutics, we continue to set new standards for quality. We are one of only a few companies that manufacture dietary supplements and over-the-counter (OTC) medicines, dictating our status as a drug GMP audited facility. We have meticulous quality standards, rigorous testing requirements, and vigilant audits and inspections - from the raw material stage, to the final product, and through to the expiration date to ensure our products are safe, and our labels are accurate. This video provides an overview of our raw material sourcing process. For more information, on the standards and testing we utilize, visit http://www.integrativepro.com/quality
Global Trends in API and Drug Product GMPs: Introduction and Overview - Section 1 of 6
 
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Lecture titled, "Global Trends in API and Drug Product for GMPs" September 2013 Michael Anisfeld of Globepharm Consulting
How to create a Rule Specifiction that validates product Information
 
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Agenda for this video includes - How to Add rule statements with suitable selections -How to add a reference table -how to validate, test and compile
Views: 2621 Informatica Support
Rx-360 Challenges to Raw Material and Supplier Risk Management
 
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Rx-360 is a consortium being developed by volunteers from the Pharmaceutical and Biotech industry which includes their suppliers. The purpose is to enhance the security of the pharmaceutical supply chain and to assure the quality and authenticity of the products moving through the supply chain. The individuals developing this concept are working in the best interest of patients. We are a non-profit organization with the mission to create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by guaranteeing product quality and authenticity throughout the supply chain.
Views: 208 Rx-360 Consortium
Quality aspects in investigational medicinal product developments
 
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Speaker: Tone Agasoster, Norwegian Medicines Agency (NOMA), Norway Session 1: Building quality documentation early during development Quality aspects in investigational medicinal product developments SME workshop: Focus on quality for medicines containing chemical entities 4th April 2014
Views: 598 emainfo
OOS/OOT for Pharma Template
 
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OOS/OOT for Pharma Template
Views: 1816 Aaron Zhang
Pharma Protocol - Pharma ERP - Module - Manufacturing
 
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This brief video shows a detailed overview of the Manufacturing module's functional specifications, design specs , process flow and the overall product architecture based on USFDA guidelines.
Views: 923 Manikandan Sarma
PVP in Pharmaceutical Applications Industry Classification, Specification & Application
 
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Get Complete Report @ http://www.bigmarketresearch.com/global-pvp-in-pharmaceutical-applications-industry-deep-research-report-market The Global PVP in Pharmaceutical Applications Industry 2016 Deep Market Research Report is an in-depth market report prepared by market analysts with valuable inputs from industry experts. The report offers an in-depth insight into the key market status, current and future market trends, business profile of key market players, market challenges along with the strategies adopted by key market players to gain a stronghold in the market. The analysis covers the changing market dynamics in terms of covering basic parameters such as product classification, applications, end-users, and cost/revenue structure. Crucial information on R&D status and technology sources of key market players of Global PVP in Pharmaceutical Applications industry is offered in the report. Furthermore, the study offers a detailed analysis of key market growth drivers and restraints along with impact analysis of the same. Table Of Content 1 Industry Overview of PVP in Pharmaceutical Applications 1.1 Definition and Specifications of PVP in Pharmaceutical Applications 1.1.1 Definition of PVP in Pharmaceutical Applications 1.1.2 Specifications of PVP in Pharmaceutical Applications 1.2 Classification of PVP in Pharmaceutical Applications 1.3 Applications of PVP in Pharmaceutical Applications 2 Manufacturing Cost Structure Analysis of PVP in Pharmaceutical Applications 2.1 Raw Material Suppliers and Price Analysis of PVP in Pharmaceutical Applications 2.2 Equipment Suppliers and Price Analysis of PVP in Pharmaceutical Applications 2.3 Labor Cost Analysis of PVP in Pharmaceutical Applications 2.4 Other Costs Analysis of PVP in Pharmaceutical Applications Enquire About This Report @ http://www.bigmarketresearch.com/report-enquiry/420318
Views: 19 Camila Ross
Water Quality for Pharmaceutical and Medical Device Processes
 
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Water is one of the most widely used raw materials in the MedTech industry; yet water systems are often overlooked as a source of contamination. With uses ranging from active pharmaceutical ingredients (APIs), to analytical reagents, to rinse water for cleaning processes, selection and production of the most appropriate quality of water is of utmost importance. This presentation will discuss water impurities, potential effects on the process, and design for removal. In addition to regulatory expectations, we will outline the basis for water quality standards development and provide guidelines for the selection of quality water attributes for processes, system qualification, monitoring, and process controls. This webinar training session is appropriate for the water system design team, water system process owners, quality control staff, and maintenance personnel. The knowledge gained from this presentation will aid in the recovery of problematic existing water systems and benefit the design of new water systems prior to build.
Views: 7579 Nelson Labs
Track & Trace Solution for Pharmaceutical Industry
 
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The solution comprises of:  Packaging level definitions up to 8- level of packing types for any product.  Product specification definition along with the level of packing -- Primary, Secondary, Tertiary etc. -- with the respective pack sizes.  Product linkage to unique trade identification number -- Company prefix & Assigned Item reference number - through system as per the Global Trade Item Numbers (GTIN) complying with the GS1 standard.  Generation unique UID no. in addition to the GTIN no. -- Batch no., Expiry Date, Mfg. Date, Mfg. Line Ref., Formulation ID, Supervisor ID -- extendable to ePedigree functions of the packaging lines.  Bar code printing / Label printing (1D / 2D as per GS1 barcode specification) on various printers -- JP Nano, Zebra, Laser -- through system. Printing also customized to any specific type of printer.  Scanning of barcoded information at the various level of packing and data storage of their inter linkage for complete ePedigree functions trace ability throughout the supply chain and the entire life cycle of the product thereby protecting against counterfeiting.  Provision of reprint option of the desired bar code information already printed.  Exception report for bar code label count that were not scanned due to any reason. The solution has been developed for Pharmaceutical industries and that complies with the existing statutory & labeling requirements for Exports and Local supplies.
Views: 3978 MINDeMPro
Phases of Pharmaceutical Industry
 
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The video-clip 'Phases of pharmaceutical industry' presents, step by step, the medicine line production. A 2D animation presents both the individual phases and the overall picture of the process. The students familiarize with the requirements and the conditions of medicine production, the required technology and the importance of health and safety specifications. What follows is the acquaintance with the methods of product qualitative control, the role of the head pf production and issues of waste management. The clip is instructional as far as medicine production is concerned and can be used as an introduction to the topic 'Industries' and 'Pharmacy'.
Views: 172068 EducationalTVGreece
Quality by Design in Product Development
 
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Paper:-Product development Part 2 Subject:-Pharmaceutical Science
Views: 81 Vidya-mitra
Annual product review - Standard Operation Procedure
 
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Order at http://www.gmp7.com/Standard-Operation-Procedures/annual-product-review_p9022.html Annual product review - Standard Operation Procedure Description An annual product review (APR) should be conducted for every commercial product. The purpose of this review is to verify the consistency of the manufacturing process, assess trends, determine the needs for changes in specifications, production, manufacturing and/or control procedures and evaluate the needs for revalidation. This APR is reported and approved in a product-specific annual product review report. Our 8-page APR SOP summarises FDA CFR expectations and PIC guidance. It also includes a 6-page, ready-to-use APR template. The SOP and template only need a small amount of site-specific modification before they can be adopted for your operations. Table of Content 1. Regulatory Reference 2. Purpose 3. Scope 4. Responsibilities and Accountabilities 4.1 Quality Assurance 4.2 Production 4.3 Quality Control 4.4 Regularly Affairs and Clinical Safety 5. Procedure 5.1 APR framework 5.2 APR tools 5.2.1 Trend analysis 5.2.1 Mean charts 5.2.2 Range Evaluation 5.3 APR report checklist 5.3.1 Recommendations from prior APR report 5.3.2 Batches manufactured 5.3.3 Batches rejected 5.3.4 Batches reworked/reprocessed 5.3.5 Deviations, Out of Specification Results (OOS) 5.3.6 Environmental monitoring data 5.3.7 Product Specification/Method Changes 5.3.8 Retain samples (US) 5.3.9 Changes effected (Change Control) 5.3.10 Analytical data 5.3.11 Validation review 5.3.12 Recalls 5.3.13 Customer Complaints and Returns 5.3.14 Adverse Drug events (US marketed products only) 5.3.15 Inspections from any official inspectorate 5.3.16 New recommendations 6. Definitions 7. Distribution 8. Attachment Annual Product Review Report Template 6 pages
Views: 3847 GMP7VIDEOS
Annual Product Reviews  New FDA Quality Metrics Guidance on Annual Product Review
 
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Click here for more Information:-http://bit.ly/2pikM0y A review, conducted annually to give an organized and comprehensive summary of all production activities, analytical and physical, Stability, Deviations, Change controls, Out of specifications recalls and market complaints, which assess the quality standards of each drug product. ▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀ Subscribe on Youtube:http://bit.ly/2oSHP1I Follow us on Facebook:https://www.facebook.com/fdaeducator/ Follow us on Twitter:https://twitter.com/FDAEducator Follow us on Google+:-http://bit.ly/2FY0GCX ▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀▄▀
Views: 59 FDA Educator
Quality Control In Parenterals
 
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Quality control deals with testing, sampling, specification, documentation, release procedure which ensure that all tests are actually carried out prior to release of material for sale or use. Until its quality judged to satisfactory.
Views: 9182 PharmaToppers
Data Conservancy Packaging Specification
 
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This video describes the new packaging tool component of the Data Conservancy architecture illustrates its use in the ELOKA project.
Views: 97 Data Conservancy
Face wash Tube Labeling Machine semi automatic tube labeler equipment cream lotion skin care product
 
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Soft tubes cosmetic pharmaceutical labeling equipment semi automatic Etikettiermaschine fuer weiches Rohr designed and manufactured by our engineer team in cosmetic&food&pharma making and packaging machineryis widely used in the daily chemical industry like cosmetic tubes labeling.We as a famous manufacturermoreover can design and produce the packaging machine according to the special requirements from customers. Application of Semi-auto Labeling Machine for Soft Tube Labeling Machine: 1. Suitable for Soft Tube such as maquillage, facial cleanser, medicine, etc 2.Widely used in cosmetic, drinks, chemical, medical, food industry etc,which highly improves productivity and product quality. Function of Soft tubes cosmetic pharmaceutical labeling equipment semi automatic Etikettiermaschine fuer weiches Rohr 1. Suitable for labeling Soft Tube object in different sizes. 2. Composed by main body, sending paper, receiving paper, bottle orientation etc parts. 3. Putting the Soft Tube to the holder by manual and fix the bottle; pressing the off-on switch; 4. Small size labeling machine, easy to operate Specification of cosmetic pharmaceutical plastic tubes labeling equipment semi auto Etikettiermaschine fuer weiches Rohr: 1.Label width: 20-200mm 2.Label length:20-320mm 3.Products Diameter: φ8mm - φ100mm 4.Products Heigth: 10mm -200mm 5.Max Outside diameter of label roll: φ240mm 6.Inside diameter of label roll: φ76mm 7.Max Labeling speed:25 m/min 8.Accuracy of labeling:±1mm 9.Power: 220V 50Hz 145W 10.Air Pressure: 0.4-0.6 mpa 11.Machine Dimension: 680mm x 660mm x 620 mm 12. Machine Net Weihgt : 60 KG Gross weiht : 90KG Our Factory since 1992 has been manufacturing the cosmetic&food making and packaging machinery.In these field we have the experience rich enough to solve the questions encountered by our customers from both home and abroad.For more information about various high quality machinery like Face wash Tube Labeling Machine semi automatic tubes labeler equipment for cream lotion skin care pr,please email via [email protected] or browse our website http://penglaichina.com. Follow us on twitter:http://www.twitter.com/jackdu007 Like us on facebook:http://www.facebook.com/jackdu999 Skype us by :turnanewleaf Call us via:0086-15811882441
Views: 5147 Jack Du
LABELING MACHINE WITH LABLE INSPECTION VISION CAMERA SYSTEM FOR BARCODE, 2D CODE, BATCH CODE
 
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E-mail : [email protected] call 91 9898070475 http://www.labelingmachineindia.net/ - Track And Trace Cartoners And Case Packers, Track & Trace System Scans Product Codes At Cartoner Infeed , This system is mainly used for quality assurance in Pharmaceutical Industry, Food & Beverage Industry, Cosmetic Products Industry, Printing Press Industry, Packaging Industry etc. The different applications of system includes:- ► To verify Label Pattern and Color Verification. ► To check and verify OCR (Optical Character Recognition), Barcode, Pharmacode, 2D code on Label. These OCR contains the detail of the product like Batch no., M.R.P., Manufacturing Date, expiry date etc. ► To check & verify the Numbers (Digits/Characters) at the time of Printing on Scratch-Cards, Recharge Vouchers, ATM/Debit/Credit Cards, Lottery Coupon, Application Forms etc. ► Most useful to "Track N Trace" system which has been recently made compulsory in many countries for Pharmaceutical Products. ► To verify the Printing Quality  TECHNICAL SPECIFICATION: ► It is totally customized solution according to different application and products. ► This system includes following hardware:  High Resolution Ethernet Camera  Mega-Pixel Vision Optics  High Intensity Illumination  Industrial PC with high Configuration  Sensors  Air/Piston based Rejection System More information Please visit www.labelingmachine.in
Views: 19437 Bhagwati India
Rango Dietrich Quality Management - 2. Product Specification Hörbücher
 
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Rango Dietrich new single Quality Management - 2. Product Specifications and Manufacturing Instructions with a preview sample. Buy this Hörbücher records from Rango Dietrich - Quality Management - 2. Product Specifications and Manufacturing Instructions: Rango Dietrich at Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Quality+Management+-+2.+Product+Specifications+and+Manufacturing+Instructions Rango Dietrich at Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Quality+Management+-+2.+Product+Specifications+and+Manufacturing+Instructions/ex/s~details,u~10069920,p1~mp3/xe/details.html Rango Dietrich at Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Quality+Management+-+2.+Product+Specifications+and+Manufacturing+Instructions www.Feiyr.com - Load up your music! Distribute your music online. Easy, fast and competetive. We publish your music, audiobooks, eBooks and other audio productions worldwide on more than 300 Download Shops and music portals like iTunes, Amazon, Spotify, Google Play, Napster, Beatport, DJtunes.com, Deezer, Djshop, Youtube, Xbox Music, Juno Download and many more. In addition, we now also publish your books as eBooks. Start selling your music today! http://www.feiyr.com/c/en/partner Rango Dietrich on Facebook: http://www.google.de/#&q=Rango+Dietrich+facebook Rango Dietrich on Wikipedia: http://www.google.de/#&q=Rango+Dietrich+wikipedia Rango Dietrich on Twitter: http://www.google.de/#&q=Rango+Dietrich+twitter Rango Dietrich on Soundcloud: http://www.google.de/#&q=Rango+Dietrich+soundcloud Track info: Artist: Rango Dietrich Title: Quality Management - 2. Product Specifications and Manufacturing Instructions Label: Pharmaudio Guidelines Date: 2014-03-07 Style: Hörbücher ID: 10243607 ISRC: DEAR41413935 This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact http://www.feiyr.com
Views: 9 Hörbücher TV
FDA/ICH requirements for Stability Program: Audio Educator
 
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Click here for more Information:http://www.audioeducator.com/pharma-biotech/fda-ich-requirements-stability-program-102413.html FDA/ICH requirements for Stability Program Presented By: Kim Huynh-Ba Know the Best Practices for Documentation of Medical Necessity, Critical Care and Other Timed Services! More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - https://www.facebook.com/pages/AudioEducator/244912592201260 LinkedIn: - http://www.linkedin.com/company/audio-educator Google+: - https://plus.google.com/102668946943256059069/posts
Views: 3522 AudioEducator
small box packing machine for medicine cartoning equipment pharmaceutical machinery plant
 
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small box packing machine for medicine cartoning equipment pharmaceutical machinery plant ماكينات صيدلية For more information about various high quality machinery,please email via [email protected] or browse our Channal at https://www.youtube.com/channel/UCZO2zKOPk7OImW9HZQpsp6A Lick us on website:http://www.chinesepacker.com Skype us by :zhang.tracy6 Call us via:0086-13262514660 Horizontal flow wrapping machine Product Description: Our entry level horizontal flow packaging machine, the machine will totally transform the way that your products are handled and wrapped. Suitable for small to medium sized food and non-food products such as chocolate, biscuits, sandwiches and baguettes,this manually fed machine can handle up to 200 package per minute. With human-machine operation controls,self alarm display the malfunction,high sensitivity optical electric color mark tracking makes it easy to use and cost effective alternative to manual packaging methods. Specification: Automatic Flow Packing Machine 1.40-230 bags/min 2.Material: stainless steel 3.Servo Service Cartoning equipment: Introduction: It is a continuous motion Carton Boxes Packing Machine,which issuitable for the packaging of snack, bottles, vials, noodle,pillow packs, etc.The machine finished running by a series of photo-electro controller to make the machine stability and guarantee the packing quality. It includes cantons in suction and open, products put into, printing batch number, sealing or option hot-glue device. The machine can be single used or linked with Filling Machine, Blister Packing Machine, Shrink Machine, Three Dimensional Packaging Machine to form a production chain. Feature: 1.International famous brand of electrical component such as PLC touch screen, frequency inverters,etc. 2.Adopt human-machine operation system. 3.Automatically displaying device for trouble, speed and finished products counting. 4.Machine running without pressing if no products or incorrect position of products. And stopping automatically if incorrect position of product into carton after return or no cartons or out of leaflets continuous. 5.No products not suction leaflet, no leaflet not suction carton . 6.Automatic detection and rejection device for lacking blister goods and leaflets. 7.Protecting automatically for overloading. 8.stable performance , operation is easy . Main Function: Automatic folding(1-4 folding) and conveying of manual leaflet, automatic maternal categorizing and feeding; automatic paper carton spreading; automatic manual leaflet and material carton packaging, synchronous (3-row) batch number printing, automatic paper carton sealing, automatic waster eliminating. Main technical parameters: Encasing speed 50-120 boxes/min Box Quality requirement 250-350g/m2 Dimension rangeL×W×H (40-250)mm×(20-170)mm×(15-90)mm Quality requirement 60-70g/m2 Compressed air Working pressure 0.6Mpa Air consumption 120-160L/min Power 220V/50Hz Motor power 1.5kw Machine dimension(L×W×H) 3100mm×1100mm×1850mm About Packing: To ensure our service quality, we will execute the following packaging standards in delivery: 1.All the products before delivery should be tested by assemble and debugging engineer, wiped up and cleaned, then wrapped by stretch film to protect it from moist. The precision part need to flexible package. 2.In addition, without standard tools, manual and other documents, and allow ex-factory confirmation sheet, the machine cannot leave factory All the products will be packed in wooden case. The exported products use plywood case to pack. The foot margin of equipment fixed tightly to make the machine can experience loading and uploading, the upward mark will be posted on the wooden case. Our services: A-The whole system The Seller ensure the whole system can get to the requested capacity, accept and cooperate with the Buyer to pass the final testing of the whole system. B-On-site installation: The Seller supply the on site installation for the whole system, but the fees including air tickets, foods, hotel and translator in this period should be paid by User,the subsidy is 50USD/day. C-Technical support: The Seller supplies the technical support of the whole use life of the system,including the capping machine,and the procedures. D-Spare parts supply: The Seller should supply the quick-wear parts with the machine, to help the Buyer n further using. In the quality guarantee period, the Seller will supply the broken parts for free, except the easy worn parts or the damage is caused by misoperation.After the guarantee period, the Seller will supply all the parts that the User need for the whole use life of the machine in cost price.
Views: 8224 Tracy
FDA's Drug Product Listing No Change Certification Webinar
 
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Drug product companies face a December 31 deadline to certify that all drug product listing information on file with FDA is up-to-date.
Views: 70 Reed Tech
Evaluation of Shelf life of Drug Products by Arrhenius equation- Part I
 
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This presentation is about estimation of shelf Life of any drug product through Arrhenius Equation. The examples in the presentation are real and were my experiences. This presentation consists of 2 Parts.
Views: 14448 Himanshu Jha
How to know about Quality Control department Role and Responsibilities || Pharma Guide
 
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QC 1st video link https://youtu.be/wjpCn3g8TZk * It is a procedure to ensure thay the manufacturing products to a defined set of quality criteria. * Quality control is that part of GMP concerned with sampling, specification, testing, documentation and release procedures. * Which ensure that the necessary and relavent tests are performed and the product is released for use only after ascertaining its quality. * Resources: Adequate facilities Qualified personnel Approved written procedures. * Tasks: Sampling Inspecting Testing Releasing or Rejecting Monitoring * Objects: Starting materials Intermediates Bulk and Finished products Returned products Environmental conditions. * Role and Responsibilities: * Examines approves or rejects incoming materials, intermediates, bulk, finished products and returned products. * Does the inspection during production(in process control). * Establishes standardizes and impliments all QC procedures and also establish the specification of each incoming materials. * Establishes specification of intermediates, bulk and finished goods together with head of production department. * Approves reprocessing instruction and rework instruction. * Reviews production records to determine errors and ensure that investigations have been conducted and corrective action taken. * Involves in all decisions concern with the product quality. * Establishing verification and implimenting all QC procedures. * Evaluating, maintaining, storing and monitoring all reference standards and retained samples. * Reviewing Batch documentation. * Stability testing of each finished products. * Maintaining correct specification of materials and finished products. * Participating in - Complaint investigations - Environmental monitoring - Gmp training. #pharmaguideradhakrishna #PharmaGuide
Views: 12459 Pharma Guide
How to evaluate the longterm stability of your product and determine its shelf-life using Stabelity?
 
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Your objectives: - Evaluate the long-term stability of your product and define its shelf-life - Define the release limits - Define the optimal experimental design to avoid testing all factor combinations - Set up a standard re-test period for your product - Identify out-of-trend results and batches - Predict long-term stability based on accelerated studies Our solution: Stabelity ☑ Stabelity generates statistics in compliance with regulatory documents such as WHO, ICH Q1A, ICH Q1B, ICH Q1C, ICH Q1E, ICH Q6A, ICH Q6B, ICH Q5C, ICH Q5E and ICH M4Q ☑ Use of Bracketing or Matrixing designs to define the total number of experiments and the relevant time-points, avoiding to test all combinations of stability factors. ☑ Decision-making tool: one graph = one decision ☑ Use of either fixed or random batch regression models to calculate the shelf-life, the release limits or a re-test period ☑ Modeling of long-term shelf-life based on accelerated stability data with Arrhenius regression models ☑ Assessment of out-of-trend/out-of-specification batches to define a reliable shelf-life ☑ Generate an e-CTD compliant report within minutes, in full compliance with authority expectations ☑ Suitable for GxP use: fully validated according to the GAMP5 guidelines and 21 CFR part 11 compliant ☑ Our statisticians provide a support (hotline) for any questions concerning the use of the software and the processing of your data ☑ Software as a Service (SaaS) application: - no installation required: no need to validate the system on site - no maintenance costs - can be accessed from any location - always the latest version available, free of charge www.arlenda.com
China and Global Pharmaceutical Glass Industry 2014 Market Size, Share, Growth, Research & Forecast
 
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Global And China Pharmaceutical Glass Industry 2014 Market Research Report Browse Complete report with TOC : http://www.marketsnresearch.com/report/181924.php The report firstly introduced Pharmaceutical Glass basic information included Pharmaceutical Glass definition classification application industry chain structure industry overview; international market analysis, China domestic market analysis, Macroeconomic environment and economic situation analysis, Pharmaceutical Glass industry policy and plan, Pharmaceutical Glass product specification, manufacturing process, cost structure etc. Browse Complete report with TOC : http://www.marketsnresearch.com/report/181924.php Then statistics Global and China key manufacturers Pharmaceutical Glass capacity production cost price profit production value gross margin etc information, and Global and China Pharmaceutical Glass capacity production market share supply demand shortage import export consumption etc data statistics, and Pharmaceutical Glass 2009-2014 capacity production price cost profit production value gross margin etc information. To Get Sample Copy of Report Visit @ http://www.marketsnresearch.com/sample/sample.php?rep_id=181924&type=E And also listed Pharmaceutical Glass upstream raw materials and down stream analysis and Pharmaceutical Glass marketing channels industry development trend and proposals. In the end, The report introduced Pharmaceutical Glass new project SWOT analysis Investment feasibility analysis investment return analysis and also give related research conclusions and development trend analysis on China Pharmaceutical Glass industry. In a word, it was a depth research report on China Pharmaceutical Glass industry. And thanks to the support and assistance from Pharmaceutical Glass industry chain related technical experts and marketing engineers during Research Team survey and interviews. Table of Contents Chapter One Pharmaceutical Glass Industry Overview 1.1 Pharmaceutical Glass Definition 1.2 Pharmaceutical Glass Classification and Application 1.3 Pharmaceutical Glass Industry Chain Structure 1.4 Pharmaceutical Glass Industry Overview Chapter Two Pharmaceutical Glass International and China Market Analysis 2.1 Pharmaceutical Glass Industry International Market Analysis 2.1.1 Pharmaceutical Glass International Market Development History 2.1.2 Pharmaceutical Glass Product and Technology Developments 2.1.3 Pharmaceutical Glass Competitive Landscape Analysis 2.1.4 Pharmaceutical Glass International Key Countries Development Status 2.1.5 Pharmaceutical Glass International Market Development Trend 2.2 Pharmaceutical Glass Industry China Market Analysis 2.2.1 Pharmaceutical Glass China Market Development History 2.2.2 Pharmaceutical Glass Product and Technology Developments 2.2.3 Pharmaceutical Glass Competitive Landscape Analysis 2.2.4 Pharmaceutical Glass China Key Regions Development Status 2.2.5 Pharmaceutical Glass China Market Development Trend 2.3 Pharmaceutical Glass International and China Market Comparison Analysis Chapter Three Pharmaceutical Glass Development Environmental Analysis 3.1 China Macroeconomic Environment Analysis 3.1.1 China GDP Analysis 3.1.2 China CPI Analysis 3.2 European Economic Environmental Analysis 3.3 United States Economic Environmental Analysis 3.4 Japan Economic Environmental Analysis 3.5 Global Economic Environmental Analysis Chapter Four Pharmaceutical Glass Development Policy and Plan 4.1 Pharmaceutical Glass Industry Policy Analysis 4.2 Pharmaceutical Glass Industry News Analysis 4.3 Pharmaceutical Glass Industry Development Trend Chapter Five Pharmaceutical Glass Manufacturing Process and Cost Structure 5.1 Pharmaceutical Glass Product Specifications 5.2 Pharmaceutical Glass Manufacturing Process Analysis 5.3 Pharmaceutical Glass Cost Structure Analysis 5.4 Pharmaceutical Glass Cost Trend Chapter Six 2009-2014 Pharmaceutical Glass Productions Supply Sales Demand Market Status and Forecast 6.1 2009-2014 Pharmaceutical Glass Capacity Production Overview 6.2 2009-2014 Pharmaceutical Glass Production Market Share Analysis 6.3 2009-2014 Pharmaceutical Glass Demand Overview 6.4 2009-2014 Pharmaceutical Glass Supply Demand and Shortage 6.5 2009-2014 Pharmaceutical Glass Import Export Consumption 6.6 2009-2014 Pharmaceutical Glass Cost Price Production Value Gross Margin
Views: 131 MarketsnResearch
2022 Forecast: Global Herbal Medicinal Products Industry Study
 
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Global Herbal Medicinal Products Market @ http://www.reportsweb.com/global-herbal-medicinal-products-market-research-report-2017 . ReportsWeb.com has announced the addition of the “Global Herbal Medicinal Products Market Research Report 2017” The report focuses on global major leading industry players with information such as company profiles, product picture and specification.
Views: 35 Linda Howard
Laboratory Investigations and Deviations - Online Course
 
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During the course of laboratory testing results will sometimes be created which will indicate a product is out of specification, or a result my seen unexpected or suspect. In addition, unplanned events can occur such as instrument breakdowns. These events need to be reported and investigated. This course will discuss how to handle these results and will cover the following topics https://learnaboutgmp.com/elearning/laboratory-investigations-deviations/
Blister Packaging Machine | Pharmaceutical Machinery Suppliers Video
 
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Blister Packaging Machine - Email: [email protected], whatsapp/line/viber:+8613600644862. The blister packing machine applies to medicine packaging, such as variety specification of sugar coated or uncoated tablet, capsule, soft gel, injection and so on. It can accomplish forming, feeding, sealing, pressing, cutting, etc automatically. And the features of this kind machine as following: High speed, high stability and high accuracy when machine running. Both the width of PVC and PTP are 260mm, which is more humanized. Flat plate is front pressure to form, roller plate type to seal, thus making the grid pattern more beautiful. It can be equipped with normal feeding system or specific pipeline feeding system according to the shape of the medicines. PLC human-machine interface control system to operate, stepless frequency inverter to control. The cutting frequency is up to 20-160 blister plates/minute (the speed is adjustable according to the format length) Heating method: inner heating type; automatic temperature control; make the heat forming and lot number printing more reliable. Equipped with camera detection, automatic eliminate convey system, and conveyor link to automatic carton packing machine Cross cutting (borderless cutting) will not waste packing materials. The blister packaging machine can be combined with Pillow-type packing machine and cartoning packing machine to realize the flow operation, reasonable structure, simple operation, improve the production efficiency and product qualification rate, reduce labor intensity and production cost, also can be connected with three-dimensional packing and heat shrink machine. We supply one line machine from blister packing to flow packing and then cartooning machine,. Email:[email protected],whatsapp/­line/viber:+8613600644862. http://youtu.be/0YBnb8qGZXI Blister Packaging Machine
Sophora Japonica Extract Rutin
 
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Name: Rutin Latin Name: Sophora Japonica L. Specification:NF11 95%Min,DAB 98%Min,EP 98%Min, Function:Anti-inflammatory Effect, Beneficial to Cardiovascular Application: Pharmaceutical field, Health Care Products http://www.chem-herb.com
Views: 233 Jessie Zhang
ISO 8573 Compressed Air Testing - Quick View
 
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Trace Analytics offers compressed air testing for manufacturers that use compressed air in their process. Compressed air sampling is key to quality assurance when compressed air is used directly or indirectly on the final product. SQF, BRC, BCAS and ISPE all recommend compressed air testing for consumer safety. We can test particles, water and oil per ISO 8573 or to your custom specification. This process is available to anyone needing to test in the manufacturing industry or needing ISO 8573 testing. This is the quick version of the process and we have a full length version available on FB, YouTube or our website. We also offer microbial testing. Contact us for more information! http://www.AirCheckLab.com Contact us if you would like to learn more!
Views: 4574 Trace Analytics, LLC
automatic linear liquid filling caps inserting lining auto filler caps insert capping equipment
 
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The machine is widely used in bottle cap factory, gasket factory, pharmaceutical factory, food product factory, household chemical plant, packaging plant and so on factory, ideal for the gasket fill in cap equipment Features of equipment: 1. It's substitute the manual operation, make the gasket fill in cap automatically, greatly improved work efficiency; 2. The gasket seal is reasonable, fast speed, high efficiency, product safety and health; 3. It is particularly suitable for the health conditions is relatively harsh that uses an occasion, avoid to the material secondary pollution, can be leave out the sterilization process; 4. The cap sorting mechanism attach cap reject function, make the reverse cap automatic return to cap sorting machine, to ensure all discharge cap mouth is upward feed in conveyer belt; 5. This machine can be disorder caps automatic pour into cap sorting machine by hoister, feed into conveyer belt after automatic sorting, and enter the turntable finally, interval feed into workstation to automatic fill in gasket after positioning the cap by turntable, automatic feed into outlet cap conveyer belt after complete the fill in gasket. 6. Adopt the conveyer positioning mechanism of mechanical drive, steady and reliable when the equipment working, suitable for various specifications of the caps and aluminum foil gaskets. 7. The complete machine adopts PLC control, have without gasket and cap to alarm function, electrical control system adopts frequency control technology, setting freely application range is widely, simple operation, stable operation, easy to clean, convenient in maintenance and durable. 8. It' has automatic detection function of finished products, the gasket not into the cap or reverse side fill in the cap, detection device automatic reject the disqualification cap to defective area. Guarantee the qualification rate of cap. 9. This machine equipped with without caps and aluminum foil etc. safety protection device, realized user-friendly operation. 10. It's has automatic counting function, and greatly improved the efficiency of the follow-up work. 11. This machine is in strict accordance with the national "GMP" standards and process requirements to design and manufacture of automatic cap fill in gasket equipment. Equipment structure composed: Automatic cap sorting mechanism: Make messy cap to arranged output and make all the cap mouth is upward. Cap conveying mechanism: Make the finished cap order and accurately conveyed to the gaskets fill in cap mechanism. The gaskets fill in cap mechanism: The gasket fill in cap, complete the gaskets fill in cap action. Reject mechanism of reverse and without gasket: Automatic reject the cap when reverse gasket and without gasket in the cap, to ensure all the caps is qualified products. Dispensing mechanism: Complete the dispensing action before the gasket fill in cap. (Optional device) Main technical parameters Specification of CAP Max. productive capacity (PCS/MIN) Power voltage (V) Total power External dimension (L x W x H) mm 20-50 160 220 1.5 3000×1500×2200 Our Factory since 1992 has been manufacturing the cosmetic&food making and packaging machinery.In these field we have the experience rich enough to solve the questions encountered by our customers from both home and abroad.For more information about various high quality machinery like automatic linear liquid filling caps inserting lining fully auto filler caps insert capping equipment ,please email via [email protected] or browse our website http://penglaichina.com. Follow us on twitter:http://www.twitter.com/jackdu007 Like us on facebook:http://www.facebook.com/jackdu999 Skype us by :turnanewleaf Call us via:0086-15811882441
Views: 5064 Jack Du
Pharmaceutical interview questions on ICH stability guidelines|Part-1
 
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What is Significant Change in Pharmaceutical Stability Testing? Or Can you explain what do you mean by significant changes? This is the one of the frequently asked question in the interview. In this tutorial you will learn how to define “Significant change” in a drug product or drug substances, according to ICH Q-1E guideline.
Views: 1338 Pharma Learners
IR Pilot Identification Test Program
 
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This program makes pass/fail judgments for test samples based on verification methods described in Pharmacopoeia and standards specified in each country, such as "Infrared Spectrophotometry" in the Japanese Pharmacopoeia and Japan's Specifications and Standards for Food Additives. In addition to identification tests for pharmaceutical and food product identification tests, the program can also be used for acceptance and pre-shipment inspections. The program calculates the difference between peak wavenumbers from standard and test samples and the difference between the peak intensity ratios and then prints a report of pass/fail judgment results. It includes spectra for the 57 substances specified in Japan's Specifications and Standards for Food Additives.
Views: 33 ShimadzuEurope
BASWEN IoT Medication Data Device
 
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Device and system specification Composition - IoT smart dispenser with taking-medication sensor and smartphone application Function - Sensor : infrared light sensor - Light : LER alert indicator - Battery : Chargable litium-ion battery or Disposable battery - Smartphone App : Security Module, Time alert, Caregiver alert, Medication history check, Data capture Baswen is seeking an efficient and strategic business model through continuous research and development of patient-side mobile medication product in healthcare field. Our product is an IoT based medication data monitoring device. This product is sensing tablets or capsules from the containers while the pills come out. This solution enables patients to increase medication adherence. Patients are able to prevent overdose and to take medicine on time. We provide global-level products and services worldwide with the development of innovative products and pharmaceutical IoT medication products for better quality of life and healthcare.​ http://www.baswen.com
Views: 301 JW kim
QC Specification -Good Documentation
 
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This video go over basic Quality department structure , function and cross functional department practices. How a QC department work in life science company and what to expected from a QC role. QC function include use Specification and test data sheet while performing the tests. Getting to know about specification structure help you present better in job interview.
Views: 168 gourav pandey
automatic counting and bottles line,capsule counting machine,tablet and pills filling line
 
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automatic counting and bottles line,capsule counting machine,tablet and pills filling line Any questions,feel free to contact me. Email:[email protected] Skype:zhang.tracy6 More information:https://twitter.com/htpmachinery Chick here to subscribe us http://www.youtube.com/channel/UCo4XjYB_mRONyQKah8jbjVw Specifications 1.used for tablet, capsule, pill filling bottle 2. can finish whole bottle filling, screwing, labeling production process automatic counting and bottles line Bottling line including: Unscrambler--Tablet counter----desiccant inserter-----screw capping machine-----induction cap sealing machine----labeling machine Unscrambler: LP-700B or LP-700C Tablet counter: SL-30/8 , SL-60/16, SL-60/16 New Desiccant inserter: SZ-100 Screw capping machine: SXG-100 Induction cap sealing machine: DG-1500B Labeling machine: TB-100
Views: 124353 Tracy
Bectochem Factory at Ankleshwar.flv
 
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About Company : • Founded in 1978 to manufacture pharmaceutical process equipment. • Bectochem produces a comprehensive range of equipment including rapid mixer granulators, fluid bed driers and processors, mills, blenders, coaters & turnkey solids and liquids manufacturing systems. • Introducing barrier isolator technology to India in 2004, Bectochem is the acknowledged expert in the specialised and technically demanding field of design & manufacture of high specification barrier containment systems. • The Industries We Serve- Pharmaceutical - API Manufacturing - Solids Formulations - Liquid Formulations - Ointment Formulations R&D Food Cosmetics • Bectochem's product range is to be found in facilities across 5 continents. We strive to provide continuous improvement in our quality and customer satisfaction, supplying right first time and on time with fast manufacturing lead times. Manufacturing Facility at Ankleshwar, Gujarat State : Gujarat is among the first state in India which is well connected with about 74000 km of roads 11 domestic airports and 1 international airport (at Ahmedabad), and the well planned Indian Railway network. Infrastructure in India derives most of its robustness from Gujarat industry as it produces 35% of India's pharmaceutical products. These above facts led us to establish our main work centre here in 1988. Our manufacturing facility in Ankaleshwar spans about 100,000 sq. ft. and is equipped with state of the art equipment.
Views: 3838 BECTOCHEM1978
Global and Chinese Pharmaceutical Tablet Testing Equipment Industry, 2009 2019
 
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Delivery of the Report will take 2-3 working days once order is placed. Market Research Report on Global and Chinese Pharmaceutical Tablet Testing Equipment Industry, 2009-2019 is a professional and in-depth market survey on Global and Chinese Pharmaceutical Tablet Testing Equipment industry. The report firstly reviews the basic information of Pharmaceutical Tablet Testing Equipment including its classification, application and manufacturing technology; The report then explores global and China’s top manufacturers of Pharmaceutical Tablet Testing Equipment listing their product specification, capacity, Production value, and market share etc. The report further analyzes quantitatively 2009-2014 global and China’s total market of Pharmaceutical Tablet Testing Equipment by calculation of main economic parameters of each company; The breakdown data of Pharmaceutical Tablet Testing Equipment market are presented by company, by country, and by application; The report also estimates 2014-2019 market development of Pharmaceutical Tablet Testing Equipment Industry. The report then analyzes the upstream raw materials, downstream clients, and current market dynamics of Pharmaceutical Tablet Testing Equipment Industry. In the end, the report makes some proposals for a new project of Pharmaceutical Tablet Testing Equipment Industry and a new project of Pharmaceutical Tablet Testing Equipment Industry before evaluating its feasibility. Overall, the report provides an in-depth insight of 2009-2014 global and China Pharmaceutical Tablet Testing Equipment industry covering all important parameters. Complete report is available @ http://www.rnrmarketresearch.com/market-research-report-on-global-and-chinese-pharmaceutical-tablet-testing-equipment-industry-2009-2019-market-report.html .
Views: 14 Nancy Freedman
How to Use Multi Function Labeling Machine ALM-71300
 
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How to Use ALM-71300 Labeling Machine http://www.printermaker.com/Multi-Function-Automatic-Labeling-Machine-for-Bottles-p1340.html Multi-function Automatic Labeling Machine for round bottles, oblate bottles, square bottles , etc. Advance The machine can simultaneously achieve two-sided circumferential surface labeling and labeling features to satisfy the flat bottles, square bottles and bottle shaped single-sided and double side labeling, the entire circumference of the cylindrical body, a half weeks labeling, widely used cosmetics industry, daily chemical industry. Optional Tape printer and inkjet printer to achieve the production date printed on the label and batch information to achieve labeling – endowed integration. Application 1.For label: self-adhesive labels, self-adhesive film, electronic supervision code, bar code, etc. 2.Applicable products: Requires the side plane, side sweeping surface, the circumferential surface attached label. 3.Industry: Widely used in cosmetics, daily chemical, electronics, pharmaceutical, metal, plastics and other industries. 4.Application examples: Head & Shoulders shampoo flat bottle labeling, Shell Lubricants flat bottle labeling, labeling and fresh wine. Specification 1.label length : 20mm ~ 200mm 2.Label width (backing paper width / mm): 20mm ~ 180mm 3.Flat or Oblate bottles size : Length : 20mm ~ 250mm Width: 30mm ~ 90mm Height: 60mm ~ 280mm 4. Round Bottles Size: Diameter : 45mm ~ 100mm Height: 60mm ~ 280mm 5.Max Outside diameter of label roll: φ280mm 6.Inside diameter of label roll: φ76mm 7.Labeling accuracy (mm): ± 1mm 8.The standard speed : 5 ~ 19m/min 9.Labeling speed: 30 ~ 160pcs/min 10.Conveyor speed : 18m/min 11.Weight : about 330kg 12. Voltage : 110/ 220V 60Hz 13.Power : 1220W 14.Machine dimensions: 3000mm × 1450mm × 1600mm Features 1.powerful, a machine can achieve four kinds of products-sided and double-sided labeling (round bottle, flat bottle, square bottle, shaped bottle). Configure round bottle positioning style cover standard mechanism, enabling single standard round bottle labeling, double standard labeling and spot labeling; 2.uses synchronous bilateral rigid plastic chain guide, automatically guarantee a bottle of neutral, the workers put into bottles and bottles of low demand docking lines, greatly reducing the difficulty docking assembly line worker jobs or be stand-alone production, can also be connected to production line; 3.Configuring spring-capping mechanism to ensure smooth product handling and high bottle itself effectively eliminate errors; 4.configure automatic bottle institutions, guided bottle automatically before separate spacing, ensure follow guide bottles, transport and labeling of stability; 5.configure two repeat standard bodies, for the first time to ensure labeling accuracy, quadratic twist roll-covered standard, effectively eliminate air bubbles and ensure the head and tail snapping; 6.intelligent control, automatic photoelectric tracking, with no object no labeling, no label auto-correction and auto-detection function labels, tags and drain to avoid wasting stickers; 7.high stability, Panasonic PLC + touch screen + Panasonic Matsushita Electric eye needle + German Leuze label sensor composed of advanced electronic control systems, support equipment 7 × 24-hour operation; 8.equipment is mainly made of stainless steel and high-alloy, in line with GMP production, the overall structure of a solid, beautiful; 9.can be stand-alone production, can also be connected to production lines, automatic product detection, unmanned production; 10.function with downtime, production counting function, power saving features, the production of digital set stop function, parameter setting protection function to facilitate the production and management; 11.optional features and components.