Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals

Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals

We all know microorganisms are present in environment everywhere, in almost all type of conditions. Also this is known all microorganisms are not harmful only 2% of population is harmful and cause infections. 98% population of microorganisms are useful in running biodiversity on the earth.  Those are harmful comes under category of pathogens.

Likewise aseptic or sterile activity regulatory bodies are concerned about contamination of microorganism in formulation other than parenterals.

Crystal M. Booth has provided a good information in following article for non sterile microbiological contamination in formulation.

Regulatory-expectations-for-objectionable-microorganisms-in-nonsterile-pharmaceuticals-0001

How To Establish An Aseptic Gowning Qualification Program

How To Establish An Aseptic Gowning Qualification Program

For aseptic area control on contamination is most important and critical job. Gowning is not given to protect your body only, it is for protection of product from viable and non-viable contamination. Many studies has proven that HUMAN is the major source of contamination in clean area and therefore now close system are first choice of aseptic product manufacturing (RABS/ Isolator / SUS).

What are the best way of gowning and how to qualify them is given in details here in this article of  Crystal M. Booth, PSC Biotech.


https://www.pharmaceuticalonline.com/doc/how-to-establish-an-aseptic-gowning-qualification-program-0001

A review of - Advanced Microbiology Techniques for Aseptic Facilities

A review of - Advanced Microbiology Techniques for Aseptic Facilities

Here is link of video for everyone's update to know where Pharmaceutical industry is moving for - The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products.

This one of the good video having many industrial experts comments on the subject and will enhance knowledge to all who are in field of aseptic and clean area facility design, operation or quality checks.

Link:

A review of - Advance Microbiology Tech for Aseptic Facilities