Tag Archives: non-sterile pharmaceutical

The importance of monitoring environmental isolates

The importance of monitoring environmental isolates, objectionable organisms | Medical Supply Company

Tracking and trending environmental isolates is a growing concern for pharmaceutical companies, since objectionable organisms remain the leading cause of non-sterile product recalls. In this blog we look at the importance of monitoring your environmental isolates, storing them correctly and adding them to your testing schedule. Objectionable organisms account for around 72% of non-sterile product recalls. […]

Ready-to-use ‘Starved Cells’ for GPT of R2A agar

Starved Cells, GPT agar, GPT of R2A agar, oligotrophic organisms | Medical Supply Company

If your lab is following the Japanese Pharmacopoeia (JP), you will be familiar with the requirement to use ‘starved cells’ for Growth Promotion Testing (GPT) of R2A agar. This agar is widely used to detect oligotrophic organisms, such as stressed or chlorine-resistant bacteria in purified or pharmaceutical water. The Japanese Pharmacopoeia states: “Prior to the […]

What are auditors looking for in growth promotion testing (GPT)?

Auditors growth promotion testing GPT | Medical Supply Company

Microbiologics have published a new post highlighting the best practices that auditors look for when evaluating growth promotion testing (GPT). By referencing the various Pharmacopoeia (Ph. Eur., USP, JP) they discuss some of the key questions pertaining to GPT:  When must you perform? What are the requirements for the challenge organisms used? Do you need […]

Should you test for Burkholderia cepacia?

Should you test / care for Burkholderia cepacia, Gram- Negative Rod | Medical Supply Company

Why you should care about Burkholderia cepacia A recent article from Charles River “Why You Should Care About Burkholderia cepacia” caught our attention and reminded us of the importance of this ubiquitous Gram-negative rod. The question of whether or not to test for Burkholderia cepacia frequently arises for all non-sterile pharmaceuticals, personal care products and […]