Category Archives: USP 797

Surface Sampling for ISO Class 5 Primary Engineering Controls

contact_plate_surface_sampling

Contact Plates and Clean-Up In the compounding of pharmaceuticals, Primary Engineering Controls (PECs) are critical in ensuring final product integrity and public safety. Equipment such as compounding aseptic isolators (CAIs) and biological safety cabinets (BSCs) must be contamination free, and this requires diligent monitoring to maintain standards to PEC ISO 5 classification. According to USP [Read More…]

Cleanroom News: Top 10 Articles of 2017

top 10

Last year, we dipped our corporate toes into the pool of industry analysis, tentatively creating articles that we thought might be of interest to our customers, partners, and the broader contamination control community. We expected that only a handful of readers would return week after week to see what scientific curiosity had caught the eye [Read More…]

Should Cellphones Be Allowed In A Cleanroom?

businesswoman texting while driving

Anyone who’s ever driven a car has been there. It’s a common enough scenario: you’re sitting in traffic on the freeway during the morning commute, the sun’s climbing slowly into the sky, its pale light casting a wan glow over the road ahead. Pausing to sip the coffee you grabbed at the drive-thru, you notice [Read More…]

Compounding Pharmacies: Exploring the Insanitary/Unsanitary Conundrum

Black mold

Introduction When it comes to pharmaceutical products, medications, or nutritional supplements, as members of the contamination control industry – and as consumers – we like to believe that they are health-promoting, safe, and pure. From a professional standpoint, we understand the critical importance of preparing, packaging, and storing materials and compounds that will be absorbed [Read More…]

Sterile Compounding – More Than Meets the Eye

sterile-compoutinding-more-than-meets-the-eye2

Sterile compounding in a pharmacy involves customization of medication mixtures in a minimal contamination environment.  Safeguarding against unwelcomed contamination is a tall order because many of the small contaminants are invisible to the eye and hidden as microorganisms.  The robust standards established by the United States Pharmacopeia (USP) Chapter <797> for cleaning and disinfecting the [Read More…]

Contamination Control News: When Honey is Not So Sweet.

Compounding Pharmacies

In Lithuanian, the noun ‘Medaus’ translates as ‘honey,’ at once a description of nature’s superlative food and a term that’s come to describe something of excellent quality. ‘That’s one honey of a car!’ we might exclaim in admiration of our neighbor’s Jaguar, for example. But excellence is not what immediately springs to mind when reviewing [Read More…]

New Rules for Compounding Pharmacies in 2016

USP 797 Sampling Swabs

After a string on contamination issues in compounding pharmacies, the FDA has expanded some of it’s definitions and adopted some changes that seek to improve patient outcomes. One of the biggest changes in 2016 has been adopting a new broader definition of compounding which before was defined by Federal Food, Drug and Cosmetic Act which [Read More…]