Resource Requirements

Facilities & Environmental

Conditions
 General
• Many factors determine the correctness
and reliability of tests and/or calibrations
performed by a laboratory. These factors
include contributions from:
– human factors
– FACILITIES & ENVIRONMENTAL CONDITIONS
– test and calibration methods and method
validation
– equipment
– measurement traceability
– sampling
– the handling of test and calibration items
 Resource Requirements: General
• The laboratory shall have available
the:
– personnel,
– FACILITIES,
– equipment,
– systems and
– support services
necessary to manage and perform
its laboratory activities.
 Facilities & Environmental Conditions

• Conditions shall be suitable for the

laboratory activities and shall not
adversely affect the validity of results
• Lab should have a comfortable working
environment:
– 20 to 25 °C
– relative humidity of 35 to 50%
– Lighting 80 to 100 foot-candle

• Measures shall be taken to ensure good

housekeeping in the laboratory.
 Facilities & Environmental Conditions

• Environmental conditions should not

invalidate results or adversely affect the
required quality of any measurement.

• The technical requirements for

facilities and environmental
conditions that can affect the
results of tests and calibrations
SHALL BE DOCUMENTED.
 Facilities & Environmental Conditions

• The laboratory shall MONITOR,

CONTROL and RECORD
environmental conditions as
required by the relevant specifications
• Activities should be stopped when the
environmental conditions jeopardize the
results of the tests and/or calibrations.
 Facilities& Environmental Conditions

• Controlled Access
– Access to and use of areas affecting the
quality of the tests and/or calibrations shall
be controlled.
• Access to the operational area of the laboratory
should be controllable and limited.
• Visitors should not have unrestricted
access to the operational areas of the
laboratory.
• A record should be retained of all visitors to the
operational areas of the laboratory
 Facilities & Environmental Conditions

• Separation of Activities/areas
– Separate areas for incompatible activities &
measures taken to prevent
contamination contamination,
interference or adverse influences
– Sample receiving and storage conducted in
designated areas separate from the main
lab.
– The laboratory areas are separated from
other sections in the building
 Facilities & Environmental Conditions

• Example: Separation of Activities/areas

for PCR analysis
– Examination Work Area
– Extraction Work Areas
– PCR Setup Work Area
– Amplified DNA Work Area
 Accommodation & Environmental
Conditions
• Storage:
– Storage areas should be
• secure to prevent theft or interference
• limited, controlled access.

– The storage conditions should be such as to

• prevent loss, deterioration and contamination
• maintain the integrity and identity of the
evidence.
• This applies both before and after examinations
 Accommodation & Environmental
Conditions
• Monitoring
– Analysis of samples should not be
performed if monitoring reveals that
required environmental conditions are not
met.

– In lab where temperature, relative

humidity and clothing can affect the
analytical results, these parameters are
monitored and recorded.
 Accommodation & Environmental
Conditions
• Monitoring
– Chemical hoods and BSC are visually
checked for proper operation before each
use.
– Distilled or de-ionized water systems are
monitored
– Routine insertion of analytical and
reagent blanks with sample analysis
detects laboratory environmental
contamination and any cross-
contamination
 Accommodation & Environmental
Conditions
• General Cleaning
–  Laboratory areas are maintained sufficiently
clean and orderly to prevent contamination
of samples and to facilitate efficient laboratory
operations.

– This include as a minimum, the following

activities:
•  sweeping or mopping floors, including walk-in
refrigerators;
• cleaning up spills immediately;
• adequately decontaminating and cleansing glassware;
 Accommodation & Environmental
Conditions
• General Cleaning continued
– cleaning contaminated equipment, removing all chemicals
upon completion of analysis, removing all contaminants
when the equipment is placed in surplus;
– disposing of waste properly
– controlling pests;
– emptying trash cans;
– vacuuming carpet;
– cleaning restrooms; and
– monitoring storage areas to ensure storage conditions are
clean and dry, there is no leakage of product, timely
disposition of materials, and proper containment
offensive materials
 Accommodation & Environmental
Conditions

DNA Lab Cleaning Record

MicroB Lab Cleaning Record

Environmental Control Record

 LABORATORY DESIGN FOR
QUALITY

• Designed in such a way so as to minimize the

environmental influences on analysis
LOCATION, LOCATION, LOCATION…..
• Lab should be completed separated from
administrative and other areas
• Locate laboratory in low traffic areas (uninvited
visitors disrupt work flow, track contamination in the
lab)
• If possible put buffer zone between lab and other
areas
• Ground floor best (Convent for brining equipment,
supplies and samples into laboratory)
• Leading to lab ensure elevators have adequate
capacity, hallways and doorways are wide
enough
 LABORATORY SIZE
• Depends on number of people, size
and quantity of equipment and
storage for samples and supplies

• Anticipate growth and make

allowances.
 LABORATORY DESIGN
• Maintain separate preparation, wash-up and
analytical areas. If possible separate rooms (If space is
limited combine preparation and analytic area)
• Peninsula bench configuration (best)
– Minimize walking during sample and preparation
– Minimizes unwanted traffic

• Keep aisles and between-bench spacing wide and free

of clutter
– aisles 3’-4’ wide
– benches 5’ apart
– allow adequate clearance between fronts of incubators
and refrigerators

Adequate clearance allows lab materials, samples and

cultures to be transported on carts rather than hand
PENINSULA BENCH CONFIGURATION
 LABORATORY DESIGN
• Walk through lab activities (when planning a bench
layout, visualize the workflow)
• Position major equipment (locate equipment where it
does not interfere with workflow, but still in proximity to
where it will be needed. eg. autoclave should be located
conveniently adjacent to media prep and wash-up

• Allow adequate space for storing supplies and holding

samples
– Designate a holding space for all samples until lab results
are completed.
– Keep supplies used regularly close to lab
– Provide storage space for dehydrated media, prepared
plates, test kits, diluents and broth media.

• Provide parking space (place to leave lab carts, space in

 LABORATORY DESIGN

Reduce the risk of contamination;

• Cupboard that reach ceiling
• Furniture and equipment installed in such a way
that there are no dust traps and are easy to
clean
• Windows and doors that close tightly to avoid
draughts
• Window blinds on the out side
• Closed cupboards for storage of documents
• Walls, ceilings, floors and furniture with smooth
surfaces, easy to clean and disinfect
• No exposed water pipes crossing rooms
• Filters for the air entering ventilation systems
 LABORATORY SERVICES
• Gas
– install only in area of laboratory where required
– more outlets increases the chance of leaks

• Electricity
• HVAC (Heating, ventilation and Air conditioning)
Temperature 200C- 250C
Humidity 35%-50%
• Water

• Waste Disposal System

• Lighting (80-100 footcandles)
 CONTAINMENT

• Prevent external contaminants from

entering lab

Containment Methods
– Separate air supply (HVAC system ) for lab
– Slight negative or neutral air pressure in lab
– Positive air pressure antechamber (Neutral air
pressure antechamber can work but less
effective)
– Positive Lab air pressure + high-efficiency
particulate arresting (HEPA) filtration
POSITIVE AIR PRESSURE ANTECHAMBER
 CASEWORK
• Wood (Plastic laminated)
+ Most economical
- Susceptible to water damage and warping
- Does not have rigid strength as metal

• Metal (Steel powder coated or electrostatically bonded pain

+ Rugged and attractive
+ Long term durability
+ Easy to clean and sanitize
- Susceptible to corrosive chemicals (strong acids/bases)
- Can rust if coating is scratched
- More costly

• Plastic Polymers
+ No corrosion, no swelling
+ Attractive
+ Easy to clean and sanitize
 COUNTERTOPS
• Laminated Wood
+ Acid resistant best
+ Economical
- Susceptible to delamination from heat and
moisture

• Solid Resin Composites

+ Extremely hard and resistant to chemicals
+ Good scratch resistance
+ Easy to clean and sanitize
- Not susceptible to water damage
 COUNTERTOPS
• Quarried Stone
+ Good when impregnated and sealed with resin
+ Resistant to staining and scratching
+ Good chemical resistance
- Easy to clean and sanitize
- Susceptible to cracking from sudden temperature change

• Stainless steel
+ Best except when concern about electrical conductivity
+ Chemically resistant
+ Heat tolerant
+ Resistant to scratches and moisture
+ Easy to clean and sanitize
- Very expensive