Ensuring maximum protection of environmental monitoring samples for manufacture of sterile medicinal products
Cherwell, specialist supplier of environmental monitoring (EM) and process validation solutions for the pharmaceutical and related industries, is highlighting how its accessory product portfolio is designed to maximise protection of EM samples in line with the new EU GMP Annex 1 and its quality risk management (QRM) focus to ensure the safe manufacture of sterile medicinal products.
Effective monitoring for microbial contamination in pharmaceutical manufacturing is vital in demonstrating strict compliance with the regulatory standards, and as such ensuring EM samples are protected is key. Cherwell has a number of solutions to help ensure the samples taken in controlled environments are secure and representative.
Andy Whittard, Cherwell’s Managing Director, commented, “I think it is clear that the launch of the new Annex 1 guidance is forcing manufacturers to look more closely at the robustness of their monitoring programs. They face a key challenge with the new zero cfu limit in Grade A spaces and the avoidance of any false positive, as well as how events post sampling are processed, for example accidental damage to culture media plates.”
Use of the correct monitoring or sampling devices and also their correct positioning are key considerations to ensure effective EM in line with Annex 1 – Cherwell has a range of products to help pharmaceutical manufacturers achieve this. For example, the SAS Super Isolator can be configured for tri-clover installation ensuring the sampling head is fixed in situ. The benefit being this creates a robust and repeatable monitoring point which removes any possible variability caused by slight differences in sampling location.
When using a handheld sampler, such as the SAS active air sampler, it may be more prudent to mount the sampler on to a tripod to enhance sampling in some locations. Cherwell has a range of tripods and stands for use with the SAS which provide improved stability, plus the flexibility to place the sampler closer to the critical point. For clean room use, a stainless-steel tripod is available.
Settle plates are notoriously easy to disrupt, either by being accidently moved or damaged, especially if they are located on the floor. The Cherwell range of stainless-steel plate stands not only provide greater protection to the plate during exposure, but are also available in a tall version to enable the settle plate to be lifted away from the floor and closer to the task.
Once the sample is collected, transport of the plate to the laboratory for incubation is the final critical step. Cherwell’s all stainless-steel plate carriers provide a convenient way to transport plates, whilst reducing the risk of accidental exposure caused by dropping.
