Biosafety Cabinet and Cleanroom Air Safety Monitoring

Routine environmental air particle monitoring plans designed to monitor the air quality of biosafety cabinets and cleanrooms, both to protect the cleanroom staff and the product as well, are tailored to individual cleanrooms and processes and are created through a risk assessment carried out by the cleanroom owner. There are a few guidelines in GMP Annex 1 and CGMP for us to follow for routine environmental particulate monitoring:

1. The air particle sampling probe should be <1ft away from the working zone in the aseptic process/manufacturing
2. Monitoring of ISO 5 areas should be done during all aseptic processing/manufacturing 
3. Monitoring of ISO 7 & 8 areas should be carried out at least weekly
4. Sampling results should be trended and appropriate alert and action levels established for each sampling location
5. Sampling in unidirectional/laminar flow areas should use an isokinetic probe so that the airflow is not disturbed by the sampling process

Air particle monitoring can be achieved in a number of ways:

Portable Particle Counters

• Quick to deploy – no installation required as the counter has its own power supply (batteries), internal sampling pump and particle counting program
• Versatile: can be used for periodic routine environmental monitoring, continuous monitoring during production and cleanroom classification to ISO 14644-1:2015, as required by GMP Annex 1 and CGMP
• Can be fully calibrated to ISO 21501-4, as required by ISO 14644-1
• 21 CFR part 11 features:
  • Secure electronic records for batch release file straight from the counter via USB, wired Ethernet or wireless Ethernet
  • Multi-level User Name and Password hierarchy for 21 CFR part 11 compliance
  • Routine environmental monitoring locations and settings from your SOP can be pre-programmed into the counter and simply selected by the technician from a list
• Excel-readable data file straight from the counter
• Hot swappable batteries are a good feature for extended continuous use, especially if the batteries can be charged in an external charger cradle
• Alternatively, portable counters can be plugged into an electrical wall socket for continuous use if there is one available

View Instructions for Use for more detail.

Environmental Monitoring Systems

• Comprehensive:
  • Particle counters located permanently at routine monitoring locations – no need for staff to move counters and no need for staff to be exposed to potentially hazardous product
  • Can also monitor differential pressure, temperature and relative humidity
• Provides trend data and reports in Excel-readable format, or PDF for batch files
• Real-time alarms and monitoring of all locations via remote p.c. monitoring

View our Facility Monitoring Systems Brochure for additional detail

Handheld Particle Counters

• Low cost
• Small and light so it can be passed through a transfer hatch between cleanroom zones/into biosafety cabinets
• Doesn’t take up much room on the environmental monitoring trolley
• Excel-readable trend data file straight from the counter

View our Instructions for Use for more detail

Injectable Drug Safety

Drugs delivered to the patient via injection/infusion such as vaccines and anti-virals have to be essentially particle-free to avoid the risk of occluding the patient’s small capillaries and in some cases, depending on the chemical make-up of the contaminating particles, there can be a risk of anaphylactic shock. Testing a batch of product can be difficult if large volumes are required to satisfy the test method, particularly where the batch size of the drug is small. However, USP<787> for particulate matter in therapeutic protein injections allows the user to complete the required safety test with as little as 0.2mL of the product. It is helpful if the liquid particle counter can be adapted to work with these small volumes and to safely hold the cone-shaped vials typically used for protein-based therapies during the test.