FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 1 of 9

For the most current and official copy, check QMiS.

Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .......................................................................................................................................1

3. Responsibility............................................................................................................................1

4. Background...............................................................................................................................3

5. References ...............................................................................................................................3

6. Procedure .................................................................................................................................3

6.1. Environment...................................................................................................................3

6.2. Environmental Monitoring ..............................................................................................5

6.3. Segregation....................................................................................................................6

6.4. Housekeeping ................................................................................................................7

7. Glossary/Definitions..................................................................................................................8

8. Records ....................................................................................................................................8

9. Supporting Documents .............................................................................................................8

10. Document History .....................................................................................................................8

11. Change History.........................................................................................................................9

12. Attachments..............................................................................................................................9

1. Purpose 

This document describes the guidelines for Office of Regulatory Science 

(ORS) laboratory facilities to ensure that the environmental conditions do not 

adversely affect or invalidate sample handling, instrumentation, analytical 

testing, and calibrations.

2. Scope

This procedure applies to all ORS laboratories.

3. Responsibility 

A. Laboratory Management:

1. Ensures laboratory facilities meet the required environmental 

conditions, including any needed separation of work areas to ensure 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 2 of 9

For the most current and official copy, check QMiS.

that analyses and calibrations will not be adversely affected within 

resources provided;

2. Ensures laboratory storage areas provide proper storage of 

samples, reagents, microbiological media, chemicals, select agents, 

standards and reference materials, and radioactive wastes and 

hazardous waste;

3. Ensures any additional laboratory conditions needed for specialized 

analyses are met, including structural, equipment needs and 

procedures for the handling and analysis of extremely hazardous 

materials within resources provided;

4. Ensures additional resources needed are identified and procured;

5. Ensures scheduled cleaning and maintenance service of the 

laboratory facility is accomplished;

6. Ensures a pest control program is in place;

7. Ensures modifications are made to the laboratory to accommodate 

new equipment, so the equipment does not interfere with the 

environmental controls in the laboratory;

8. Implements environmental control programs in the laboratory;

9. Performs continual laboratory surveillance to ensure proper 

conditions are being met, and

10.Recognizes when environmental conditions are not met and 

adversely affect test or calibration results.

B. Staff:

1. Plans and conducts laboratory operations in designated areas;

2. Monitors and records environmental conditions in their areas;

3. Identifies and implements any environmental controls needed to 

complete sampling, analysis and calibration, and ensure these 

factors do not adversely affect the quality of the work;

4. Practices good housekeeping practices; and

5. Practices proper handling and storage of hazardous waste, as 

defined in the Hazardous Waste Plan, so as not to adversely affect 

laboratory operations.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 3 of 9

For the most current and official copy, check QMiS.

4. Background

None

5. References

A. Center for Disease Control, National Institutes of Health. Biosafety in 

microbiological and biomedical laboratories, current edition. 

Washington, DC: United States Department of Health and Human 

Services, Public Health Service.

B. CRC Handbook of Laboratory Safety.

C. Code of Federal Regulations. Title 29, Part 1910.1450. Washington 

DC: Government Printing Office.

D. Code of Federal Regulations. Title 29, Part 1910.1000. Washington DC: 

Government Printing Office.

E. American National Standards Institute/American Industrial Hygiene 

Association (ANSI/AIHA) Z9.5 Standard - Laboratory Ventilation 

Guidelines

F. National Science Foundation (NSF)-ANSI 49 Class II (Laminar Flow) 

Biosafety Cabinetry

G. ISO/IEC 17025:2017, General requirements for the competence of 

testing and calibration laboratories, Section 6.3.

H. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018.

6. Procedure 

6.1. Environment

A. The laboratories are designed to provide space, engineering controls, 

and proper environmental conditions for optimal sample storage, 

sample handling, analysis, and calibrations, in accordance with general 

laboratory practices, safety, and applicable Federal, State and local 

regulations.

B. Facilities consist of laboratories, office areas, storage rooms, and 

special purpose areas. Laboratories are sectioned by testing 
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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 4 of 9

For the most current and official copy, check QMiS.

compatibility and design capabilities. Floors in the laboratories are 

constructed from a material that is resistant to most chemical spills and 

easily disinfected. Microbiology labs are designed to minimize areas 

with cracks or fibers that could serve to accumulate debris and serve as 

an area for growth of microorganisms. Floors are clean, dry, and in 

sound condition so there are no tripping hazards.

C. Laboratories are equipped with climate and ventilation control. The 

temperature and humidity within the laboratory are maintained within 

limits for the proper performance of each test or analysis and 

maintained according to the manufacturer’s specifications for the proper 

operation of instruments. A comfortable working environment is 

considered 20 to 25o C with relative humidity of 35 to 50% depending on 

geographical area. In general, the work areas should be free of 

temperature extremes that are hazardous to health or which interfere 

with safe operations. Laboratories where toxic materials are handled 

are under negative pressure to adjoining areas with 8 to 12 air changes 

per hour. High hazard laboratories, clean rooms/isolators, animal 

facilities, and Biosafety Level III suites have unique working conditions. 

Work, storage areas, and restrooms are free of noxious odors. Exhaust 

ventilation is maintained for 24 hours per day in any area where 

chemicals are stored or used. No laboratory air is recycled through the 

building. The supply vents should not exceed 50 feet per minute (FPM) 

airflow.

D. The laboratory maintains sufficient illumination for the procedure being 

performed and the noise levels conform with Occupational Health and 

Safety Administration (OSHA) guidelines. Lighting is at suggested level 

of 80 to 100 foot-candle intensity unless it affects the analysis and other 

lighting is needed. Specialized lighting may be needed in areas where 

direct sunlight can be deleterious to samples, reagents and media or 

can interfere with instrumentation or analysis. 

E. Workbench space is sufficient to perform operations and to prevent 

clutter. Benches are constructed of a material that is easily disinfected 

and impervious to most chemical spills. Bench space is convenient to 

sinks, water, gas, suction, and electrical outlets needed to properly 

carry out tests or analyses offered by the laboratory. 

F. The laboratories are equipped with chemical hoods to capture 

hazardous or odorous materials used or produced in the analyses and 

to protect employees from hazardous concentrations of airborne toxic 

substances. Class II biosafety cabinets (BSC) are provided for 

biohazardous analysis and sterility work. Laminar flow cabinets are not 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 5 of 9

For the most current and official copy, check QMiS.

used because of the lack of employee protection. Sufficient hood space 

should be provided to laboratory employees. Face velocities for 

chemical hoods must be within 80 to 120 FPM with minimal distortion of 

air movement (cross-drafts) through the face of the hood from activities 

or sources in the room. Maintenance is performed routinely on these 

systems.

G. Local utilities companies provide electricity and water. An auxiliary 

power generating system is in place to provide emergency power for 

hazardous or sensitive operations. Recommended parameters for 

electrical power include voltage regulation to within 5 to 10% of nominal 

with minimum line transients and a grounding system. Voltage 

regulation is important for instrumentation to maintain stable, drift-free 

operation. Constant-voltage transformers are in place to regulate 

voltage where line fluctuations occur. All instruments and equipment 

are grounded. Type I or Type II water is used for dilutions, preparation 

of reagent solutions and final rinsing of glassware. Ground fault 

interrupters are used in wet areas where there is a shock hazard. 

Electrical service is supplied, and circuit breakers are identified in 

electrical boxes.

H. Separate storage areas of sufficient size are present in the laboratory to 

ensure that glassware, portable instrumentation, microbiological media, 

supplies, reagents, solvents, chemicals, hazardous or regulated wastes 

and reference standards and materials are properly stored. Separate 

storage areas prevent contamination or degradation, ensure the 

laboratory is in compliance with regulatory authorities, meet security 

needs, assure personnel safety, and minimize clutter. Chemicals and 

solvents are stored compatibly and in accordance with the 

manufacturer’s guidance in the Material Safety Data Sheet (MSDS) and 

the fire code. Storage areas for samples are to accommodate retention 

of samples for the times and conditions needed to protect their integrity. 

Shelving units in storage areas are braced to prevent collapsing of the 

shelves.

6.2. Environmental Monitoring

NOTE: Calibrations or analysis of samples are not performed if monitoring 

reveals that required environmental conditions are not met. 

A. In laboratory rooms where temperature and relative humidity affect the 

analytical results, temperature and humidity are monitored and 

recorded. In some instances, the test is placed in a smaller controlled 

environment such as an incubator. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 6 of 9

For the most current and official copy, check QMiS.

B. Chemical hoods and BSCs are visually checked for proper operation 

before each use. BSCs and chemical hoods are certified annually. As a 

minimum, airflow velocities in hoods are measured for the following two 

situations: (a) Hoods are measured annually, before use with a very 

toxic, low permissible exposure limit (PEL) or time weighted average 

(TWA) value material, and (b) whenever there is a fluctuation in 

performance. Biosafety cabinets are additionally monitored for 

particulates whenever there is a concern. A magnehelic gauge on the 

BSC monitors the static pressure on the high efficiency particulate 

HEPA filter to determine when the filter needs changing.

C. Bench surfaces and hoods in microbiology laboratories are monitored 

periodically for microbiological contamination. Additionally, air sampling 

is performed periodically to monitor for microbiological contamination in 

these laboratories. Routinely, a series of antimicrobial cleansers are 

used in the microbiology laboratory at the end of an analysis, at the end 

of the day, or in the event of a spill to minimize any potential microbial 

contamination. In the chemical laboratories, air monitoring is conducted 

whenever there is a complaint of odors or other suspect indications of 

the presence of a chemical. Monitoring is mandatory when the 

chemical is regulated by Occupational Safety and Health Administration 

(OSHA) as a toxic air contaminant in 29 CFR, Part 1910.1000 and there 

is reasonable evidence of employee exposure. 

D. The laboratory shall define the use of water and ensure that the water is 

fit for that use. Distilled or de-ionized water systems are monitored at 

least monthly to ensure the water meets method specific quality 

attributes. Water used for microbiology analyses is verified monthly for 

acceptable levels of chlorine and aerobic plate count. Water used for 

pharmaceutical analyses is verified to meet the requirements of FDA 

Inspection Technical Guide, Number 46 Water for Pharmaceutical Use. 

Additional tests are performed on the water systems as defined by the 

laboratories to ensure the water is fit for use. 

E. In laboratories that perform metal analysis, benches, hoods and 

glassware are monitored periodically for metal contamination.

F. Routine insertion of analytical and media blanks with sample analysis 

detects laboratory environmental contamination and any crosscontamination. 

6.3. Segregation

A. Separate areas are maintained for incompatible activities, and 

measures are taken to prevent cross-contamination. For example, no 

organics are used in a perchloric acid hood.
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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 7 of 9

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B. Sample receiving and storage is conducted in designated areas which 

are separate from the main part of the laboratory.

C. The laboratory areas are separated from other sections in the building, 

such as Administrative Services, Investigation Branch, Compliance 

Branch, lunchroom and conference room facilities.

D. Areas of specialized testing are separated from general work areas.

E. Chemical, standards, reference materials and cultures are stored 

separately from samples.

F. Microbiology media preparation and sterilization areas are separated 

from work areas to prevent contamination of clean media.

G. Where feasible, volatile organic operations will be physically separated 

from solvent and sample handling areas and vented.

6.4. Housekeeping

A. Laboratory areas are maintained sufficiently clean and orderly to 

prevent contamination of samples and to facilitate the efficiency of 

laboratory operations.

NOTE: Contractors perform a portion of the housekeeping 

responsibilities under the direction of the immediate supervisor or the 

principal analyst. Contractors are not allowed in certain laboratories 

without escort and guidance.

B. Housekeeping, as a minimum, includes the following activities: 

1. sweeping or mopping floors, including walk-in refrigerators;

2. cleaning up spills immediately;

3. adequately decontaminating and cleansing glassware;

4. cleaning contaminated equipment, removing all chemicals upon 

completion of analysis, removing all contaminants when the 

equipment is placed in surplus; 

5. disposing of radioactive, infectious, DEA-controlled, select agent, 

hazardous, and universal wastes properly;

6. controlling pests; the use of aerosol agents to eliminate pests is 

discouraged as they can cause cross contamination to samples for 

several chemistry analysis, such as pesticides; 

7. emptying trash cans; 

8. vacuuming carpet; 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 8 of 9

For the most current and official copy, check QMiS.

9. cleaning restrooms; and

10.monitoring storage areas to ensure storage conditions are clean and 

dry, there is no leakage of product, timely disposition of materials, 

and proper containment of offensive materials.

7. Glossary/Definitions 

A. Accommodation – This refers to space in the laboratory area and how it 

is suited for the work performed.

B. Extremely hazardous – This is a characteristic of chemical compounds 

that are highly toxic or dangerous, such as arsenic or radioactive 

materials. 

C. Clutter – This refers to a crowded, confused, or messy collection of 

things.

D. Incompatible - Activities or analyses which interfere or adversely affect 

other activities or analysis in the same area are considered 

incompatible. 

8. Records 

A. Temperature and humidity records

B. Maintenance, certification and performance records on chemical hoods 

and biosafety cabinets

C. Surface and air sampling records for contamination

D. Maintenance and performance records on water systems

E. Pest inspections

9. Supporting Documents 

A. ORA Laboratory Manual, Volume III, Section 1 Environmental Health 

and Safety

10. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.3

Revision #: 02

Revised:

05/15/2019

Title: 

Facilities and Environmental Conditions Page 9 of 9

For the most current and official copy, check QMiS.

1.1 R LMEB LMEB

1.2 R 10/01/03 LMEB LMEB

1.3 R 08/15/08 LMEB LMEB

02 R 05/15/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision 

# Change

02 Revisions made to align this procedure with new ISO/IEC 17025 and AOAC 

requirements. Revision to formatting and policy clarifications were also made.

12. Attachments

None