Tag Archives: stability testing

Walk-In or Reach-In Chamber?

What to choose, a Walk-in or Reach-In Chamber

Which should I buy, a Walk-In or Reach-In Chamber? This is a question that sometimes comes from Pharma Customers but is also relevant for Plant Growth Chambers. The names of these chambers tell you the difference and the points below will add detail. Let’s deal with it as pros and cons. Walk-In Pros Size is […]

Chamber Mapping & Qualification

chamber mapping & qualification

Introduction In Chamber Mapping and Qualification we describe how mapping is used in the Pharmaceutical and Medical Devices Industries and the mapping service DACTEC provides. Each market’s regulatory authority e.g., the FDA (Food & Drug Administration) in America, the HPRA (Health Products Regulatory Authority) in Ireland mandates the validation of environmental conditions that can affect […]

Stability Testing – An Overview

What is Qualification in the Pharmaceutical Industry?

Introduction In Stability Testing – An Overview we look at stability testing requirements – chamber choice , validations requirements, IQOQPQ & IPV considerations. To prove the shelf life of a drug in a certain market, the manufacturer must store it at a relevant temperature and humidity for a specified time. This is done in a […]

Stability Testing Seminar

What is Qualification in the Pharmaceutical Industry?

In association with Weiss Pharmatechniik, DACTEC hosted a seminar on 26th September 2013 on Stability Testing. The seminar considered stability testing in compliance with ICH (International Conference on Harmonisation) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, EU GMP (Good Manufacturing Practice), GAMP5 (Good Automated Manufacturing Practice), FDA 21 CFR Part 11 […]

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