BIOLAB – Air Quality Services is a division of B.G.E. Service & Supply Ltd. and was created in 1984 to meet the demand of customers for the certification of biosafety cabinets, fume hoods, HEPA filters and laminar flow benches. We have grown to include cleanrooms, level 3 laboratories, pharmacies and operating rooms. Based in Calgary, we service Western Canada.
Compounding Pharmacy Facilities Certification, BIOLAB- Air Quality Services is now pleased to offer USP <797> compliance solutions to pharmaceutical sterile compounding facilities under the direction of a registered cleanroom certification professional for sterile compounding facilities.
With over 37 years of field experience in air filtration, BIOLAB offers a combination of <797> services including primary (PEC) secondary engineering control (SEC) testing and certification to CETA – CAG 003 (cleanrooms, biosafety cabinets, LFB Isolators), air and surface environmental monitoring in association with an accredited laboratory.
<USP> testing services are executed in accordance with BIOLAB standard operating procedures (SOP’s) which are updated to remain compliant with current national and international industry standards.
Testing Services – Testing and certification of ISO Class 5 Primary Engineering Controls (PECs) including biosafety cabinets, laminar flow clean benches, clean air devices and isolators, buffer and clean rooms.
Testing can include:
- HEPA Filter Integrity Test
- Airflow Velocity Profile
- Temperature and Humidity Readings
- Pressurization Particle Counts
- Viable Sampling (both air and surface)
- Biosafety Cabinet Certification (where applicable)
- Room Air Exchange Rate
- Consulting services are available for the planning, designing and construction of Sterile Compounding Pharmacies.
- Videotaped in-situ air pattern analysis (smoke studies) of ISO Class 5 PECs under dynamic conditions for Inspection compliance if requested.
- Isolator Performance Qualification (required for Isolators outside of buffer areas)
- Hazardous drug preparation and storage area airflow and pressure testing.
- Full engineering control repair services for biosafety cabinets, clean benches, Isolators and cleanrooms.
Please contact us at:
BIOLAB – Air Quality Services
A Division of B.G.E. Service & Supply Ltd.
Calgary, AB T2H 2K7