DryCal Calibrators and Bioreactors
Regulating the environment and metabolic rate of microorganisms in bioreactors is essential to successful production of pharmaceuticals or vaccines. Ensuring that bioreactors stay hermetic and free of foreign or excess gas species can be difficult without opening gas flow lines. Calibrating gas flow from MFCs without opening gas flow lines is essential in order to prevent contamination, and DryCal piston provers are the ideal tool for the job.
When using DryCal calibrators, simply install a downstream tap, or A/B valve, to divert the gas flow through the MFC away from the reactor and into a different pipe. Here you can connect your DryCal calibrator and perform your gas flow calibration. This means you get a highly-accurate calibration with no system contamination and no downtime.
Keeping Calibrations in the Cleanroom
Mesa Lab’s portable DryCal piston provers help you keep calibrations in the clean room, saving you valuable time and money. This means MFCs don’t need to be removed from the clean room, which could cause devastating downtime. Instead, the FlexCal can be set up in your clean room to do in-situ calibrations and calculations, keeping your production cycle on track and within regulation. The FlexCal is an easy-to-use, compact handheld solution that is perfect for utility feed line calibrations, and can be utilized in cramped spaces such as utility rooms or other control instruments.
Regulatory and Compliance
ISO 17025
ISO 17025 is a globally recognized and accepted accreditation obtained by calibration laboratories to demonstrate their competence in providing calibration services.
NIST
NIST is the National Metrology Institute (NMI) for the United States who provides calibration services across metrology disciplines and maintains the US inventory of national measurement standards.
ANSI Z-540
ANSI Z-540 has been partially superseded by ISO 17025 and Z-540 part 3, and is primarily used as an accreditation standard for calibration laboratories supporting operations of select departments of the US Government.
FDA 21 CFR 820.72
21 CFR 820.72 defines the quality system requirements to operate and maintain inspection, measuring, and test equipment used in the production of food and drugs supplied to the US market.
SEMI Test Methods for Gas Delivery Systems
SEMI creates and maintains standards and test methods used by global manufacturers of microelectronics and solar equipment to assist them in specifying system components, maintaining performance specifications, and commissioning and troubleshooting the gas delivery sub-system of process tools.
OIML R137
R137 is a recommendation from the International Organization of Legal Metrology (OIML) intended to standardize terminology, technical requirements, metrological controls, and other factors for flow meters of any technology that measure gases and gaseous fuels that are not liquefied, multi-phase, or steam.