For the production of safe medical devices, pharmaceuticals or biotherapeutics, manufacturing environment conditions are of paramount importance. By controlling and monitoring the manufacturing environment, potential bioburden contamination can be limited, helping to ensure a high sterility assurance level for finished products.
Pacific BioLabs’ microbiology lab has experience in working with manufacturers to develop and implement effective environmental monitoring programs, including air and surface sampling as well as process water testing. Our microbiologists can visit your facility to gather samples, or train your personnel in proper sample collection technique. Additionally, we can provide the necessary supplies for routine sampling and monitoring.
Both viable (microbial) air samples and non-viable air samples can be taken. Typically, viable air samples are collected using a Rotary Centrifugal (RCS) Air Sampler using TSA air strips. Viable air samples can also be taken from a facility’s compressed gas systems. Non-viable particles are measured using a laser diode instrument with the ability to simultaneously measure particles of various sizes including the two most commonly used particle limits in the medical device and pharmaceutical industries of greater than or equal to 0.5 µm and greater than or equal to 5.0 µm.
Environmental Monitoring Services
- Environmental Monitoring Sample Collection
- Environmental Monitoring Performance Qualifications (EMPQ)
- Environmental Monitoring Supplies – contact plates, fall-out plates, air sampler strips
- Enumeration and Reporting
- Viable and Non-Viable Particles Measurement
- Trend Analysis of EM Data