Archives for January 2019

How should we Keep Cleanrooms Clean

Controlling microbial ingress into the cleanroom is a critical concern for the entire cleaning and disinfection process. Components, personnel, carts, tanks, tools, cleaning supplies, and instruments that are transferred into the clean area should be clean and free of contamination. Gross contamination is easier to prevent than to correct.

Updated Guidance for Compounding Facilities 503B

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” This revised draft guidance describes FDA’s policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility’s operations.

Happy New Year

The team at Aseptic Enclosures wishes you peace, joy and prosperity throughout the coming year.


Thank you for your continued support and partnership. We look forward to working with you in the years to come.