216 R.I. Code R. 216-RICR-60-05-5.8

Current through December 26, 2024

Section 216-RICR-60-05-5.8 - Physical Plant, Equipment, and Supplies

A. Each analytical laboratory shall be housed in well lighted, sanitary, properly vented quarters equipped with hot and cold running water, and toilet facilities and shall contain ample space to process and examine the samples commensurate with the total workload. Furthermore, said analytical laboratories shall:

1. be in distinct and separate locations from living quarters unless provisions exist for separate entrances and plumbing fixtures;

2. have ample workbench space, be well lighted and have sufficient water, gas, suction, electrical outlets and sinks;

3. have adequate and proper storage space for all chemicals including explosive, flammable, corrosive and caustic materials;

4. have flooring composed of non-porous material in laboratory areas where acids, caustics, and solvents are used;

5. have adequate temperature and humidity controls as may be required for proper performance of tests and operation of instruments affected by environmental conditions;

6. have adequate electrical supply; and

7. have adequate refrigeration for samples, standards, and reagents used in testing

a. food for consumption may not be stored in refrigerators containing laboratory materials.

B. The laboratory shall possess suitable equipment required for certified analyses that shall meet the requirements of the methods. All instruments shall be physically located on site.

C. The laboratory shall have sufficient glassware and plastic labware necessary for the analyses. Glassware shall be borosilicate glass or other corrosion-resistant glass. It shall be free of cracks and chips. Markings and etchings shall be legible. Volumetric flasks, pipettes, and other glassware used for volumetric analysis shall be class "A".

D. All precision equipment and instruments shall be calibrated and checked for accuracy at regular intervals as required by the method and the laboratory's quality assurance policies. Documentation of calibration and accuracy checks shall be maintained. Records of service by a qualified instrument service organization shall be maintained.

E. Balance range and sensitivity shall be appropriate for the application for which it is used. Balances shall be kept clean and free of corrosion and spillage and shall be checked daily with weights meeting ASTM Type I, Class 1 or 2 specifications with values that bracket the laboratory's weighing needs. Records shall be maintained that include acceptance criteria for the checks. ASTM weights shall be recalibrated every five (5) years or immediately if nicked or corroded. Non-reference weights may be used but shall be calibrated every six (6) months against ASTM type 1, 2 or 3 weights.

1. All balances shall be calibrated annually by a professional balance service.

F. All incubators, refrigerators, ovens, and water baths shall contain calibrated thermometers.

G. Thermometer range and graduation increments should be appropriate for the application for which it is used. Glass thermometers shall be checked for accuracy annually, and other types of thermometers quarterly, by comparing with a NIST traceable thermometer at the temperatures of interest. Thermometers shall be tagged with the date of accuracy check and the correction factor (which may be zero). There shall be no separation in the liquid column of glass thermometers.

H. Analytical reagent grade chemicals are required for analyses unless otherwise allowed or specified by the analytical method.

I. Bottles of dehydrated microbiology media shall be dated when received and dated when opened. Media shall not be used beyond the manufacturer's expiration date or within one (1) year from opening, whichever is sooner It shall be discarded immediately if caked or otherwise deteriorated. Prepared, prepackaged media are permitted.

J. All plastic labware used for microbiology shall be clear and non-toxic.

K. For chemical analyses, reagent water for general use shall be distilled or deionized and have a resistivity value greater than 0.5 megohms/cm or a conductivity value of less than 2 microhmos/cm at 25°C. Quality checks shall be made according to specified analytical method requirements, but at least monthly, with a conductivity meter. All such quality checks shall be recorded.

L. For microbiological analyses, reagent water shall meet all criteria listed in the following table:

PARAMETER	LIMITS	FREQUENCY
resistivity or	> 0.5 megohms/cm	monthly
conductivity	< 2 micromhos/cm	monthly
Pb, Cd, Cr, Cu, Ni, Zn	< 0.05 mg/L per contaminant and < 0.1 mg/L total	annually
total chlorine residual	none detectable	monthly
Heterotrophic plate count	< 500/mL	monthly
bacteriological quality of reagent water	Ratio of growth rate: 0.8 to 3.0 (see Standard Methods, Section. 9020B. This test is not required if laboratories use water that meets the criteria for Types I and II water as defined in Standard Methods, Section 1080).	annually

M. All reagents and solutions shall be labeled to indicate identity, concentration, storage requirements, expiration dates, and any other pertinent information.

N. All reagents and solutions shall be dated when received and opened. No materials shall be used beyond their expiration dates.

O. All laboratory prepared reagents and solutions must be labeled with preparation and expiration dates. No laboratory prepared materials shall be used beyond their expiration dates.

216 R.I. Code R. 216-RICR-60-05-5.8

Amended effective 4/30/2019