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Development and Manufacture of Commercial ELISA Kits(ELISA Kit의 공통적인 개발 및 제조) Development and Manufacture of Commercial ELISA Kits The rigorous research and development process and strict manufacturing conditions of commercially produced ELISA kits offer a number of advantages for clinicians and medical research. In Europe, most diagnostic companies operate according to the internationally recognised quality assurance system, ISO13485 and the tests CE marked according to .. 2020. 5. 26.
ELISA Development Guide / ELISA 개발 가이드 https://www.creative-diagnostics.com/ELISA-Development-guide.htm ELISA Development Guide - Creative Diagnostics Developing an ELISA An ELISA system consists of 4 technical elements: 1) ELISA plate-coating strategy 2) Antigen resources and Antibody pairs 3) Conjugating/labeling strategy 4) Enzyme and chromogen 1. ELISA Coating Strategy When developing a new ELISA for www.creative-diagnostics.com .. 2020. 5. 26.
연질캡슐 제조 공정(2) (Manufacture of Soft Gelatin Capsules) https://www.pharmapproach.com/manufacture-of-soft-gelatin-capsules/# Manufacture of Soft Gelatin Capsules - Pharmapproach.com Manufacture of soft gelatin capsules: This article provides an overview of the basic components of soft gelatin capsule shell as well as the various meth... www.pharmapproach.com Manufacture of Soft Gelatin Capsules Softgels are manufactured using the following methods 1... 2020. 5. 14.
연질캡슐 제조 공정(How to Make Softgel Capsules: The Complete Guide) 출처: https://www.saintytec.com/how-to-make-softgel-capsules/ How to Make Softgel Capsules: The Complete Guide - SaintyTec Today’s guide will focus on how to make Softgel capsules. It will take you through the Softgel capsules formulation, ingredients, equipment, and other processing procedures, among other critical aspects. By the end of it all, you will not only know how to www.saintytec.com 의역/.. 2020. 5. 12.
[PDA News] How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 of 6) https://pda.inloop.com/en/article/137316?utm_source=ElasticEmail-sb-pda&utm_medium=newsletter&utm_campaign=pda-1984-s-en-080520&itd_did=1984&itd_uid=42067 How to Achieve Quality by Design (QbD) in a New Pharmaceutical Fill Line: Activity Organization (Series Part 6 of 6) Over the previous five Blogs in this series we have discussed the critical quality attributes to consider in a robust Quality .. 2020. 5. 11.
[PDA News] Quality Risk Management in Annex 1; 6.1_20/04/23 https://pda.inloop.com/en/article/136917/quality-risk-management-in-annex-1-6 Quality Risk Management in Annex 1; 6.1 The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in al pda.inloop.com The use .. 2020. 5. 8.
[PDA News] Quality Risk Management Principles in Annex 1, Section 2_20/04/23 https://pda.inloop.com/en/article/136832/quality-risk-management-principles-in-annex-1 Quality Risk Management Principles in Annex 1, Section 2 The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in .. 2020. 5. 8.
[PDA News] Cleanroom Process Risk Assessment Per Annex 1_20/03/01 https://pda.inloop.com/en/article/137266/cleanroom-process-risk-assessment-per-annex Cleanroom Process Risk Assessment Per Annex 1 In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one. Process Risk Assessment: Why it’s importan pda.inloop.. 2020. 5. 8.
[PDA News] Isolator Launch in South Korea(에이프로젠의 아이솔레이터(optima) 도입과 관련하여)_20/04/30 Isolator Launch in South Korea To date, very few filling and capping machines with isolator technology have been installed in South Korea, let alone in Asia. All of this will soon change. Both Oh-sung Na (Aprogen Biologics) and Peter Kim (Optima Korea) are certain of it because Aprogen pda.inloop.com [원문 위 링크 참조] * 의역/오역 있음. Isolator Launch in South Korea Optima Pharma GmbH / April 30 To date, v.. 2020. 5. 7.
EU GMP Annex 1과 FFS(Form-Fill-Seal) / 수액제 제조공정 8.97 Form-Fill-Seal (FFS) units include blow moulding from thermoplastic granulate and thermoforming from thermoplastic film, typically known as Blow-Fill-Seal (BFS) and Vertical-Form- Fill-Seal (VFFS), respectively. VFFS process is an automated filling process, typically for terminally sterilized products, that may utilize a single or dual web system which constructs the primary container out o.. 2020. 3. 24.
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