Regulations and guidance documents are periodically updated. This is true in many applications across the pharmaceutical and biotechnology industries. While these changes are needed to help the industry adapt to current Good Manufacturing Practices, adjusting to the changes can be difficult for small and large companies alike.
In regards to environmental monitoring (EM) for total particulate counts, the international standards organization (ISO) 14644-1 was revised in December 2015. ISO 14644-1:2015 describes the acceptable levels of particulates allowed in cleanrooms and associated controlled environments. The standard also describes how many sample sites are required based on the size of an environment.
Previously, a calculation was provided in the standard that allowed users to determine the amount of samples required to establish the classification of air cleanliness. With the revision, the amount of required samples changed and this information is now presented in a table format. In many cases, the updated number of samples required increased with the standard revision.
In order to be compliant with the updated standard, existing and new companies need to adjust (or establish) their environmental monitoring programs to ensure the minimum number of total particulate sample sites are represented and the locations of the sites chosen are properly justified. Remaining compliant or establishing compliance to changing regulations with limited resources is difficult. This is where PSC Biotech™ can help.
PSC Biotech™ provides custom fit options to help companies obtain a compliant EM program. Experienced consultants are available to help companies develop and establish compliant environmental monitoring programs. PSC Biotech™ services may include performing risk assessments, sample site selection, sample site justification, sample frequency, writing reports, establishing the environmental monitoring program, writing standard operating procedures, writing protocols to establish a compliant EM program, or even executing the program to free up the companies valuable resources.
In addition to ISO 14644-1:2015, Annex 1 (EU GMP Annex 1: Manufacture of Sterile Medicinal Products – revision November 2008) is also currently being revised. At this time, a draft has been released for public comment. However, when the revised standard becomes effective, PSC Biotech™ will be there to help clients with the transition to continued compliance.