The new certifications, which cover Elastomer Cure Date/Shelf Life (Declaration of Compliance 2.1), KHK Certification for Japan and Surface Roughness, help customers address safety requirements
Brooks Instrument, a world leader in advanced flow, pressure and vapour delivery solutions, has released three new certifications available for its SLA Series and SLA Series Biotech mass flow controllers (MFCs) and metres, adding to its wide offering of product documentation.
The new certifications, which cover Elastomer Cure Date/Shelf Life (Declaration of Compliance 2.1), KHK Certification for Japan and Surface Roughness, help customers address emerging safety, legal and regulatory requirements for materials used in bioprocessing, chemical and petrochemical operations.
MFC instruments precisely measure and control the delivery of gases to production systems and chambers such as bioreactors. Critical applications like biopharmaceutical, chemical and petrochemical processes rely on MFCs to deliver exact amounts of pure gases, including oxygen, nitrogen and carbon dioxide.
Certain regulatory and safety requirements call for certification and documentation of calibration protocols or other declarations about the materials of construction in the “wetted path” of the MFC, where the process gas flows through the device.
The additional certifications include:
This certification lists the cure dates and shelf life of the elastomers used in the assembly, indicating that the elastomeric material has complete traceability and optimum physical properties for a given application.
This certification is often required on MFCs purchased by global OEMs selling critical systems into Japan or for end users in Japan. These systems are primarily used in petrochemical catalyst research markets; however, semiconductor manufacturing and power generation can also have these requirements.
This states the average surface roughness (surface finish) of the MFC flow path.
Responding to increased industry demand, Brooks Instrument recently developed special biotech options for both its industry-leading SLA5800 Series MFCs and its hose-down/wash-down suitable SLAMf Series thermal MFCs. Available biotech-specific documentation includes certifications for USP, FDA and ADI-free O-rings and valve seats; 2.1 certification for materials of construction (wetted path); plus National Institute of Standards and Technology/ICC gas-specific calibration certification for traceability.
The SLA5800 and SLAMf Biotech both feature a high turndown ratio, an extremely low leak rate valve, an enhanced sensor design and pre-calibrated multigas pages for air, carbon dioxide, nitrogen and oxygen. The Biotech offering is specifically designed for bioprocessing and other life sciences applications to enhance gas flow control range, reduce the total cost of ownership (TCO), enable process recipe flexibility via multiple gas pages and satisfy regulatory compliance requirements.
For these MFC platforms, the certifications and documentation offered by Brooks Instrument help bioprocessing equipment OEMs and end users respond more easily to the evolving requirements for cGMP (current Good Manufacturing Practices). They can also benefit anyone responsible for safety-critical industrial processing operations.
“We continue to see increased demand from customers for our certifications because it saves them time and effort in their documentation processes,” said Steven Kannengieszer, Global Marketing Director. “We added the capability to provide these specific certifications to enhance our proven SLA5800 Series and SLAMf Series MFCs.”