Description
Check biosafety boxes
Check boxes and laminar cabinets are needed to make sure that the box effectively performs its functions: it provides the necessary protection for the operator and / or product. Checking the microbiological safety boxes after installation is carried out according to such indicators as protective efficiency, clean zone class, speed of incoming and outgoing air flows, integrity of installed filters.
General requirements for laminar boxes (biosafety boxes)
GOST R EN 12469-2010 gives the following definition of microbiological safety boxes:
Microbiological safety cabinet: Ventilated restricted space designed to protect the operator and the environment from aerosols resulting from working with potentially dangerous and dangerous microorganisms by removing air into the atmosphere by filtration.
Biosafety boxes usually provide a high cleanliness class in the work area due to the high air exchange rate and the use of fine air filters (with a filtration class not lower than H14), and manufacturers of laminar boxes often indicate the ISO cleanliness class or the clean zone type under GMP in the technical documentation on the box.
In fact, any microbiological safety cabinet (BMB) is a local clean zone (isolation device) according to GOST R ISO 14644-7-2007 "Cleanrooms and associated controlled environments. Part 7. Isolation devices (clean air shelters, glove boxes , insulators and mini-environments) "and can be classified and tested in accordance with the procedures given in GOST R ISO 14644-3-2007" Cleanrooms and associated controlled environments. Part 3. Test methods ".
Why do I need to check the laminar boxes?
Requirements for the class of purity and degree of protection can vary significantly depending on the purpose, scope and type of laminar box. But in any case, in order to confirm that the laminar cabinet still fully fulfills its protective function, it is necessary to periodically inspect and maintain it.
Thus, in the pharmaceutical industry, laminar boxes are most often used to create a local clean zone of class "A" for the implementation of aseptic filling processes with a product. GMP rules govern testing of HEPA filters in clean areas for leakage after each maintenance and replacement of filters.
In medical and microbiological laboratories, the main purpose of biosafety cabinets is to ensure the protection of the operator, as well as to protect the product from cross-contamination with particles and microorganisms. In particular, GOST R 52905-2007 (ISO 15190: 2003) Medical Laboratories. Safety Requirements, clause 16 establishes the requirement for annual verification of compliance of laminar cabinets and microbiological safety cabinets.
In addition, practice shows that the inspection of boxes allows timely identification of factory faults and errors made during installation and replacement of filters that cannot be identified with the naked eye. The assurance that the biosafety box is correctly mounted and works as it should, and is the main advantage that regular box testing provides.
Check biosafety and laminar boxes after installation and maintenance
Microbiological safety boxes must be tested for compliance with the class by the manufacturer, and subsequently subjected to periodic tests - after installation and after maintenance or at certain intervals to confirm compliance with the manufacturer’s requirements and to identify the need for service.
Tests carried out during periodic inspection of microbiological safety cabinets
Determination of cleanliness class (such as clean zone), if the technical class of the manufacturer claims box cleanliness class
Measurement of air velocity in the working opening and inside the box
Visualization of the air flow to determine the direction of motion of the steady air flow
Determination of air flow entering and leaving the box
Leak Filter Testing
Tests for leaktightness of the case during periodic testing are not carried out, the test for retention in the working opening in accordance with GOST R EN 12469-2010 "Biotechnology. Technical requirements for microbiological safety boxes" when checking boxes after installation and maintenance can also be reduced to checking compliance manufacturer, determine the direction and measure the speed of the steady air flow.
Box Check Protocols
Based on the test results, a report on the testing of biosafety cabins is provided, including measurement protocols of purity class, air velocity, filter integrity and other parameters, as well as, if necessary, test reports with all primary data.
