A Biological Safety Cabinet (BSC) is an essential piece of equipment in many laboratories dealing with hazardous biological materials. BSC Certification is a measure of quality, safety and performance that ensures your BSC is adhering to industry standards and enables you to safely handle your critical materials. Having this certification is essential to operating in a safe manner and enables you to meet the safety and compliance requirements for research, development, production and other laboratory applications. In this guide, we will discuss what documents you need to provide to receive BSC Certification.
Verifying Installation and Performance of the BSC
When verifying the installation of a biological safety cabinet (BSC), the first step is determining the correct criteria for operation. Each BSC has specific materials and components designed for specific and accurate performance. As such, the model number, serial number, electrical information, and other pertinent information should be recorded in order to ensure that the operational criteria for the cabinet are properly configured. After verification of the BSCs components and performance requirements has been completed, all electrical connections should be checked, checking both shut-off switch and fuses for proper operation. Additionally, all air flow and pressure parameters should be tested using a calibrated flow hood, while the air noise is measured in order to maintain the highest performance possible.
Ensuring Accuracy of Cabinets’ Surrounding Environments
In order to maintain a suitable environment for safe use of a biological safety cabinet, it is necessary to ensure all parameters of the surrounding environment. This includes the external factors of air supply temperature, relative humidity, pressure, and air flow, as well as temperature and relative humidity inside the cabinet. To ensure the highest safety standards, these parameters should be measured and recorded prior to startup. Additionally, all windows and doors should be sealed off with plastic and any internal walls should be sealed from airflow. All air locks should be tested and the cabinet should be turned off and on several times to ensure proper operation of the BSC.
Understanding Appropriate Practices for Working Within the BSC
It is also important to understand the appropriate practices for working within the biological safety cabinet. This includes wearing proper protective gear, such as a lab coat, facemask, and goggles, as well as ensuring that no exposed skin is left exposed. Additionally, all working must be performed within the cabinet, never beyond the BSC’s front edge. All materials and hazardous materials should be handled in a safe manner, never directly handled with hands or unprotected arms and always placed on a tray within the cabinet. Furthermore, a designated area in the BSC should be used for preparation of food, drink, and material samples, and all materials should be removed from the cabinet prior to closing the cabinet door.
Documentation for Confirming Equipment Qualifications
In order to ensure the proper operation of a biological safety cabinet, the proper documentation must be available to confirm the equipment qualifications. This includes submitting a copy of the manufacturer’s certificate, which confirms the manufacturer’s statement of compliance with ANSI Standard Z9.5 (2009) or EN 12469 (2000). Additionally, the required corrective maintenance records should detail the action taken to correct any failure in the BSC’s performance. Finally, the inspection report must be completed and signed by a qualified technician, and the report should include the description of any deficiencies found during the inspection process and the action taken to correct them.
Testing Efficiency for Proper Airflow Within the Cabinet
In addition to verifying the conditions of the surrounding environment and ensuring correct setup and operation of the BSC, it is also necessary to ensure the proper airflow within the cabinet. The airflow should be measured using a hand-held airflow device and the data points should be documented in the inspection report. The evaluation should confirm that the airflow is within the manufacturer’s specifications and regulatory requirements. Other tests, such as face velocity tests, can also be completed to further verify the accuracy of the airflow in the cabinet.
Explaining Regulatory Requirements for BSC Tuning and Maintenance
Once the BSC is in operation and the airflow has been verified as being within the manufacturer’s and regulatory requirements, it is necessary to explain the regulatory requirements for BSC tuning and maintenance. All BSCs must be tuned or recalibrated on a regular basis to ensure that operator safety is not compromised and to maintain the highest performance levels. Additionally, regular maintenance must be performed on both the BSC and the surrounding environment. This includes cleaning and maintaining the BSC’s filter and other components on a regular basis.
Accessing Tools and Resources for Certification and Compliance
In order to ensure compliance with regulations and certifications, it is important to access the necessary tools and resources. This includes materials such as manuals, back-up components, and filters as well as technical and laboratory support from the manufacturer. Additionally, technical inquiries can be made with the manufacturer and professionals can be contacted to ensure that the BSCs in use are valid and certified for use. Professional technicians should also be present for periodic maintenance and certification of the BSCs.
Determining Maintenance Exemptions for BSCs with a No-Touch System
For BSCs with a no-touch system, performing corrective maintenance and tuning may not be necessary. This is because the no-touch systems feature automatic controls that maintain a safe environment regardless of external influences. The maintenance requirements for these cabinets are typically less than those for manual systems. Furthermore, when using a no-touch system it is important to obtain and use only the components necessary for certification and compliance and to ensure that the no-touch components are regularly tested and maintained.
Confirming Qualification of Suppliers and Installation Professionals
It is also important to confirm the qualifications of any installation and suppliers used when purchasing a BSC. This includes verifying the qualifications of any sales representatives, equipment suppliers, and technicians. Additionally, the competency of the installation professionals should be verified, and their certifications must be checked. All contracts should be reviewed and signed prior to installation, ensuring that the installation professional is certified for the job and that the terms and conditions of the agreement are in line with the applicable laws and regulations. All of this should be documented and kept on file for future reference.
Conclusion
The process of obtaining BSC (Biological Safety Cabinet) certification can be complicated and daunting, but with the right preparation and knowledge, it can be achieved. By having all the necessary documents, such as the manufacturer and external certifying body certifications, in place, the certification process can be completed quickly and successfully. The BSC certification can provide piece of mind for both the laboratory staff and those in contact with the equipment, ensuring the highest levels of safety and security for everyone involved.