In the world of pharmaceuticals, environmental safety is imperative. Medicines need to be pure and free of any foreign contaminants.
Purity standards for oral medications have high limits set for bacteria and fungi. Injectables such as vaccines have no tolerance for even the minimum amounts of contaminants.
Contamination Sources
Pharmaceutical manufacturing requires the use of cleanrooms, which require periodic certification to ensure the environmental safety of products and staff.
However, cleanrooms are susceptible to everyday contamination from personnel, supplies, equipment, and in some unfortunate cases, equipment and engineering control failure.
A carefully planned and executed environmental monitoring (EM) program needs to include monthly surface sampling to monitor the effectiveness of the measures used in contamination control within the cleanroom setting.
Why is Environmental Testing Important?
Monthly surface sampling is critical to identify specific threats to the purity of the products. By correctly identifying these contamination threats, pharmaceutical labs, compounding pharmacies, and vaccine research facilities can make informed decisions on correcting the contamination source.
Data obtained from the monthly surface sampling test provides critical information on the product’s potential impurities, affecting whether a production batch is apt for consumption.
Frequency of Testing
The frequency of environmental testing depends. Current best practices recommend weekly sampling for high-risk compounding, while medium-risk level compounding will remain compliant with industry standards by testing monthly. For low-risk compounding settings, quarterly testing is acceptable.
Additionally, it’s advisable to increase surface sampling frequency whenever there is new or inexperienced compounding staff or when employees have no history associated with environmental sampling, media fill testing, or gloved fingertip sampling.
Not Sure Where to Begin? Allometrics Can Help
Allometrics provides the perfect solution for low, medium, and high-risk pharmaceutical labs and compounding pharmacies.
We recommend pharmacies that have never performed surface sampling before to integrate surface sampling with Gloved Fingertip Sampling during media fill-kit testing. Additionally, it’s advisable to perform surface sampling together with viable air sampling.
From our extensive experience, to obtain the best results, we recommended you do random surface sampling and gloved fingertip sampling at the end of the workday. This practice will reveal how clean your staff is keeping their gloves and direct compounding area (DCA).
Allometrics Services
At Allometrics, we offer media fill-kits and gloved fingertip sampling. We can coordinate to have our technicians pay a scheduled visit to your facility to collect the samples, or if you prefer, we can send the sampling kits to you, and your staff can collect and mail the samples to the testing facility.
Media Fill-Kits
Our media fill-kit can help verify your sterile compounding pharmacy’s personal aseptic technique and other cleanroom applications.
- We offer kits for low, medium, and high-risk procedures
- All test components come in a self-contained ready-to-use kit
- Every kit includes a results log sheet
- Kits include detailed instructions and diagrams for easy use
- You receive expert technical support from our staff
- If you prefer, our technicians will visit your location to collect the samples
- Kits will help you comply with USP <797> guidelines
- Surface Sampling
- Air Sampling
- Sterility Tests
Glove Fingertip Sampling
Allometrics glove fingertip sampling provides a fast and convenient way for pharmacies to monitor the microbial burden of each laminar airflow workbench’s work surface.
Our contact plates are ideal for determining viable counts on smooth, dry surfaces, as well as personnel clothing, gloves, and hands.
Contact us today to learn more about our monthly surface sampling services.
WE CAN HELP YOU STAY OPEN!
YES! We can help you keep your pharmacies open & operating safely! We offer both Surrogate Bacterial and Air Sampling and Molecular Testing for COVID-19.
