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. […]
Tag Archives: growth promotion testing
25
Apr
Apr
Accurately counting the number of colony-forming units (CFU) on an agar plate forms the basis of quality control microbiology testing for pharmaceutical, cosmetic, food and environmental industries. Traditionally, colony counts were performed manually but this method is time-consuming, and can lead to issues with results, such as technician to technician variability and human error, not […]
08
Apr
Apr
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 […]
01
Oct
Oct
Medical Supply Company recently attended the Microbiologics EMEA Distributor Meeting in Berlin. It was great to get updates on the product line, hear about exciting new projects and meet fellow distributors from all over the EMEA region. Thank you to Peter Penn and the rest of the Microbiologics team for a great few days of […]
25
Mar
Mar
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 […]
11
Feb
Feb
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 […]