Abstract

Jan. 12, 2023 – Brooks Instrument, a world chief in superior circulate, strain and vapor supply options, has launched three new certifications accessible for its SLA Collection and SLA Collection Biotech mass circulate controllers (MFCs) and meters, including to its extensive providing of product documentation.

The brand new certifications, which cowl Elastomer Treatment Date/Shelf Life (Declaration of Compliance 2.1), KHK Certification for Japan and Floor Roughness, assist clients deal with rising security, authorized and regulatory necessities for supplies utilized in bioprocessing, chemical and petrochemical operations.

MFC devices exactly measure and management the supply of gasses to manufacturing programs and chambers comparable to bioreactors. Essential functions like biopharmaceutical, chemical and petrochemical processes depend on MFCs to ship actual quantities of pure gasses, together with oxygen, nitrogen and carbon dioxide.

Sure regulatory and security necessities name for certification and documentation of calibration protocols or different declarations concerning the supplies of development within the “wetted path” of the MFC, the place the method fuel flows by means of the machine.

The extra certifications embody:

Elastomer Treatment Date/Shelf Life (Declaration of Compliance 2.1): This certification lists the remedy dates and shelf lifetime of the elastomers used within the meeting, indicating that the elastomeric materials has full lot traceability and optimum bodily properties for a given utility.

KHK Certification: This certification is commonly required on MFCs bought by international OEMs promoting important programs into Japan or for finish customers in Japan. These programs are primarily utilized in petrochemical catalyst analysis markets; nonetheless, semiconductor manufacturing and energy era also can have these necessities.

Floor Roughness: This states the typical floor roughness (floor end) of the MFC circulate path.

Responding to elevated {industry} demand, Brooks Instrument lately developed particular biotech choices for each its industry-leading SLA5800 Collection MFCs and its hose-down/wash-down appropriate SLAMf Collection thermal MFCs. Out there biotech-specific documentation consists of certifications for USP, FDA and ADI-free O-rings and valve seats; 2.1 certification for supplies of development (wetted path); plus Nationwide Institute of Requirements and Expertise/ICC gas-specific calibration certification for traceability.

The SLA5800 and SLAMf Biotech each characteristic a excessive turndown ratio, a particularly low leak fee valve, an enhanced sensor design and pre-calibrated multigas pages for air, carbon dioxide, nitrogen and oxygen. The Biotech providing is particularly designed for bioprocessing and different life sciences functions to reinforce fuel circulate management vary, cut back the overall price of possession (TCO), allow course of recipe flexibility by way of a number of fuel pages and fulfill regulatory compliance necessities.

For these MFC platforms, the certifications and documentation supplied by Brooks Instrument assist bioprocessing tools OEMs and finish customers reply extra simply to the evolving necessities for cGMP (present Good Manufacturing Practices). They will additionally profit anybody liable for safety-critical industrial processing operations.

“We proceed to see elevated demand from clients for our certifications as a result of it saves them effort and time of their documentation processes,” mentioned Steven Kannengieszer, international advertising and marketing director. “We added the aptitude to offer these particular certifications to reinforce our confirmed SLA5800 Collection and SLAMf Collection MFCs.”

For a downloadable Approvals Information and extra data on all Brooks Instrument MFC approvals and certifications, go to the web site.

For extra details about SLA Collection mass circulate controllers, go to this web site.

About Brooks Instrument

Since 1946, Brooks Instrument has been a frontrunner in precision fluid measurement and management expertise. Offering instrumentation for circulate, strain and vapor supply, the corporate serves clients in biopharmaceutical and different high-tech industrial manufacturing and course of industries.

With manufacturing, gross sales and repair areas within the Americas, Europe and Asia, Brooks Instrument has the world’s largest put in base of mass circulate controllers. Its broad household of merchandise consists of the UNIT Devices, Tylan and Celerity manufacturers.

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