Microsoft Word - BYLAWS 9_26_10

OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

Appendix A: Equipment

Table 1. Calibration and verification of equipment or systems

Equipment /System

Action

Frequency

Autoclaves

Calibrate temperature sensing system

At installation (or initial use)

Verify accuracy of temperature sensing system

Annually

Verify maximum temperature achieved

Each day

Verify performance with biological sterility indicator

Weekly

Uniformity of temperature A At installation (or initial use) and annually thereafter.

Stability of temperature

At installation and annually as needed B

Automated colony counters

Verify accuracy against manual count

Annually

Balances

Verify mass measurement

Each day of use

Calibrate C

Annually When moved to different location or after repair

Chromatographic Systems (GC, IC, LC)

Verify detector response for the analytical methods D

At least once with each batch

Dispensing equipment and vial fillers used in Microbiology

Verify mass/volume measurement at each volume dispensed Verify ability to achieve and sustain vacuum Verify vacuum gauges against traceable calibrated gauge

At installation and each day of use

Freeze-dryers, vacuum ovens

At installation and annually thereafter At installation and annually thereafter

Hydrometer, reference

Calibrate

Every 2 years

Hydrometer, working

One point comparison to reference hydrometer

Annually

08/09/2018