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USP Class VI, ADI-Free, What Does it All Mean for Your Bioprocess?

Mass Flow Controllers (MFCs) are critical instruments in the bioreactor, responsible for maintaining precise gas control during the development of biologically active pharmaceutical grade cells and tissues. Key gasses including N2, O2, Air and CO2 flow through the MFC and into the bioreactor to control the cell growth andmust not be contaminated by foreignmaterials in the gas supply. This is especially important for pharmaceutical products, such as insulin and other drugs, which are injected into the body.

(Learn more about the role of the MFC in the bioreactor in our Blog post: Boosting Bioreactor Performance by Enhancing MFC Accuracy).

Many MFCs use elastomer sealing materials, so they should be certified as safe for these critical applications.  Brooks’ SLA series with Biotech Options, described in more detail below, can offer industry certifications (USP Class VI/ADI-free) for all elastomeric material in the MFC’s gas stream (wetted path) including:

  • Valve seats

  • O-rings  

For a complete description and definition of pharmaceutical material classifications, please see Certifications of Elastomer O-Rings for Mass Flow Controllers Explained.

What does USP Class VI stand for?

USP stands for United States Pharmacopeia, a private (non-government) organization responsible for the quality and safety of medical devices and foods. For plastics, there are six different classes based on duration and application.  Class VI is the most stringent and requires multiple tests to verify the lowest level of toxicity, and certifies that there are no harmful reactions or ill effects caused by chemicals contained in the plastic.

What is ADI-Free / BSE-Free / TSE-Free?

ADI free certifies that the raw materials used in production of the elastomer contain no Animal Derived Ingredients (ADI). When production of the elastomer contain no ADI with respect to source, manufacture and treatment, they cannot transmit Prion diseases such as Bovine Spongiform Encephalopathy (BSE)  and Transmissible Spongiform Encephalopathy (TSE) . The certification includes a statement from the elastomer manufacturer certifying that there no substance of animal origin used to manufacture the product. When you see ‘CFR 21 FDA 177.2600' on MFC elastomeric material, it means that it is on the FDA list of base elastomers that are recognized as inherently safe and classified as GRAS (Generally Recognized as Safe).

As mentioned above, MFC’s, including Brooks’, have elastomeric O-rings and valve seats in the wetted patch. So, when MFC’s are used in critical Biopharmaceutical applications, system designers and operators will often require the ADI free designation.

Regulatory Requirements for Biotech MFC

Brooks SLA with Biotech Options

To serve the unique requirements of Biopharmaceutical Bioreactor, Brooks Instrument has created two SLA5800 Series Biotech options packages, both built on the proven performance of the industry-leading SLA Series MFC: the SLA Series Biotech Performance and the SLA Series Biotech Premium.

The Performance Package Includes all the benefits of the standard SLA including high stability and repeatability, plus extended turndown (up to 250:1); very low leak control valve; pre-calibrated gasses (N2, O2, Air & CO2) and Biotech (welded) sensor).

The Premium materials package includes all elastomers in the wetted path of the SLA Biotech Option, including O-rings and Valve Seats, are USP Class VI and ADI Free, and include a full package of certificates. Additionally, each premium package will have 2.2 Material Certifications – certifying the composition of all materials in the wetted path –and International Calibration Traceability – calibrations traceable to NIST or other international metrology standards.. With these certifications, you can be confident  that your Brooks Instrument MFC will provide only the purest gas delivery within your Bioreactor. For an additional fee, add Material Certification 3.1 for those processes which  require full material traceability.

Currently, Class VI-ADI Free elastomers are not a regulatory or industry requirement for MFC’s used in bioreactors. But, biopharmaceutical system designers and operators are concerned enough about BSE and TSE to want these special Elastomers in their MFC when manufacturing injectable proteins such insulin or vaccines. The Brooks Biotech SLA with Premium Materials package fulfills these advanced requirements.

Read more about the benefits and specifications of the SLA5800 Series Biotech Mass Flow Controller, everything your bioprocess needs from an MFC.

About The Author

Tench Forbes
Global Product Manager

Tench is the global product manager for thermal mass flow controllers at Brooks Instrument.

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