OMA Consulting Protocol Review: OMACON-2019-2

2.2

Good Laboratory Practices

2.2.1 Reference materials or standards must be obtained directly from the producer or distributor and be accompanied by a certificate of analysis. 2.2.2 Methods will include appropriate blanks and check standards 2.2.3 One or more technicians should prepare samples and a second or more technicians should perform the assays on “blind” coded samples. 2.2.4 All samples must be fully randomized and labeled with a code so that the analyst performing the assays is unaware of the level of analyte being tested. The BIOMILK 300 LAC assay and its components (KITCLAC, KITMLAC1, KITMLAC2) are not considered a hazardous substance or mixture according to regulation (EC) No. 1272/2008. These substances are not classified as dangerous according to directive 67/548/EEC. The following safety risks may be associated with the test components. Inhalation : May be harmful if inhaled. May cause respiratory tract irritation. Ingestion : May be harmful if swallowed. Skin : May be harmful if absorbed through skin. May cause skin irritation. Eyes : May cause eye irritation. Wear appropriate protective equipment which includes but is not limited to protective eyewear, face shield or safety glasses, lab coat, and appropriate gloves. All work should be conducted in properly equipped facilities utilizing the appropriate safety equipment. Individuals should be trained in accordance with applicable regulatory and company/institution requirements before working with chemicals. BIOMILK 300 LAC Methodology (Appendix 1) 2.4.1 Storage: The Biotests are shipped at room temperature, vacuum packed and with silica gel crystals to protect them from atmospheric humidity. Once delivered, they must be kept between 3-8 o C, before expiration date. 2.4.2 To hydrate the Biotest prior to use (this process should be carried out at least 24 hours prior to use), remove the silica gel crystals from inside the Safety

2.3

2.4

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