What is a clean room? A cleanroom (GMP cleanroom), in my mind, is a combination of engineering design, fabrication, finish and operational controls (control strategy) that are required to convert a “normal” room to a “clean room”. This blog will attempt to explain the necessary characteristics of a regulated company clean room not producing potent…
Clean room turn down is a growing discussion in the Pharma industry and is usually reflected in corporate policy; if you google ‘sustainability’ and a top ten pharma company name, you’ll find taglines like GSK’s “Our Planet – Our Responsibility”. Sixty-five of the top 100 listed companies in Australia are reporting their sustainability credentials in…
PharmOut is a multi-disciplinary team of expert pharmaceutical architects and engineers, we are Australia’s leading pharmaceutical clean room designers, working for cosmetics manufacturers, non sterile and sterile pharmaceutical manufacturers around the world to provide Architecture and Engineering services. Manufacturers, often set a challenge for PharmOut’s process engineers to scale up or replicate processes. PharmOuts standard…
I want an innovative cleanroom design, the use of the word “innovation” is perhaps the most overused ‘buzz’ word in the design and documentation of health sciences facilities, the intent is certainly not over-used, in the sense of the recognition of the increasingly evident acceptance and embrace of concepts driven as simple solutions to complex…
This quick clean room design checklist is part of a number of free suggestions, tools or tips put together by our (frustrated) staff to try circumvent a poor clean room design. 1. Stakeholder consultations Has everyone who has a stake in the clean room been consulted? This includes: Maintenance – ask them what will need…
In its first major revision since the original release in 1999, ISO 14644-1 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the changes, but more importantly, how the changes affect the current PIC/S Guide to GMP for Medicinal…
In its first major revision since the original release in 2000, ISO 14644-2 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the changes, but more importantly, how the changes affect the current PIC/S Guide to GMP for Medicinal…
How familiar are you with the common concepts of GMP? If you feel you are up to the challenge, test your knowledge by taking the GMP Quiz Master challenge, if you are brave enough, login and leave your details, or you can do the test anonymously. Want to read “The story of Joe and his…
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