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: pharmaceutical
14
Apr
Apr
As all microbiologists know, counting bacterial colonies manually can be a monotonous and eye-straining task. To overcome this, many labs are looking towards automation to cut down on the time spent manually counting and free up the technician’s time for other tasks. ProtoCOL 3 is a next-generation automatic colony counter for regulated labs that require […]
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 […]
18
Apr
Apr
Come join Medical Supply Company and Isolation Technology at Pharmig 2019, where we will be on hand focusing on: Microbiologics ABE Airwel In particular the Airwel Plus with Self-Check, “the only air sampler on the market that allows users to verify on-site it is still operating within calibrated parameters” Enbiogroup Microjet When: – 15th & […]
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 […]