Facilities and Equipment
Version 5.0, August 2012
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services,
under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research
Support Services (CRSS).
Objectives
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2
List the requirements of laboratory facilities with regard
to work space
Describe the importance of appropriate facility
maintenance
Describe the importance of maintaining accurate
laboratory equipment
Describe methods used to verify accuracy of laboratory
equipment
Describe procedure for documenting maintenance,
calibration, and corrective actions
Describe optimal maintenance of reagents
Overview
Laboratory
Facilities
Environmental
Control
Equipment
Maintenance
Reagents
3
Data Storage
Facilities
Reagents
Inventory
Equipment
Inventory
Pre-Assessment Question #1
Which of the following are necessary for laboratory
facilities to ensure high standards of quality work, data and
safety?
A. Spills should be cleaned when convenient
B. Provide a safe environment for personnel
C. Proper lighting should be provided to ensure sufficient
visibility
D. A and B only
E. B and C only
F. A and C only
4
Pre-Assessment Question #2
The following can occur in facilities with inadequate
laboratory space:
A.
B.
C.
D.
E.
F.
5
Frequent laboratory accidents
Increased incidences of specimen loss or mix-ups
Sub-optimal equipment performance
Likelihood of incorrect results being reported
All of the above
A and B only
Pre-Assessment Question #3
Maintaining accurate laboratory equipment is important
for:
A.
B.
C.
D.
6
Generation of accurate results
Minimizing the costs of repair
Reporting results in a timely manner
All of the above
Pre-Assessment Question #4
DAIDS Good Clinical Laboratory Practices (GCLP)
requires that pipettes are checked for volumetric accuracy
and reproducibility and recalibrated at what defined
frequency?
A.
B.
C.
D.
7
Monthly
Annually
At minimum every 6 months
Every 2 months
Pre-Assessment Question #5
Why is it important for clinical research laboratories to document
temperature monitoring and maintenance activities for laboratory
equipment, including calibration and quality control (QC) testing?
A. It is a GCLP requirement
B. It ensures maintenance of an effective Quality Management
systems
C. It provides evidence of compliance to documented procedures
and policies
D. It assists in easy identification and corrections of problems
associated with inadequate performance of these activities
E. All of the above
F. A and B only
8
Pre-Assessment Question #6
Which of the following are required for reagent labeling per
GCLP guidelines?
A.
B.
C.
D.
E.
F.
9
Lot number and expiration date
Open and reconstitution date
Date received from manufacturer
A and B
B and C
A and C
Facilities
DAIDS GCLP Guidelines
Laboratories should be designed so that safety of
employees and quality of
work are not compromised.
10
Laboratory Facilities
Access restriction to authorized personnel
Availability of break rooms and office areas
Data storage areas
Evacuation plans
Specimen integrity
11
Fixtures
Safety
Equipment
Bench Space

12
Should be
impervious to
spillages and
disinfectants

Should
include fire
extinguishers,
eyewash,
emergency
showers,
smoke
detectors, fire
alarms, etc.
Plumbing

Should
have sinks
with elbow
taps
Shelving


Should prevent
containers from
falling
Should never
store liquid or
corrosive
chemicals on
shelves above
eye-level
Safety Signage
Should be placed in relevant
laboratory areas and be visible
Escape Route
Corrosive
Hazardous
13
Explosive
Flammable
Toxic
Biohazard
Eyewash
Fire Extinguisher
First Aid
Work Areas
Housekeeping
Work Space
Lighting
14
• Document daily cleaning activities
• Clean spills immediately
• Adequate for proper specimen handling
• Provide safe environment for personnel
• Ensure sufficient visibility
Personnel Traffic
• Limit personnel traffic
• Maintain unobstructed walkways
Segregation of
Testing Activities
• Provide logical flow of work to prevent mixups and specimen loss
Facilities
Sample
integrity
Equipment
performance
Unsuitable
facilities
affect
Personnel
safety and
competency
15
Compliance
conditions set
in the test
Data Storage Facilities
16

Separate areas should be
provided for data storage.

Adequate security unauthorized personnel
should not have access to
archived data.

Archive should be secure.

Facilities should be floodproofed, fire-proofed, fire
resistant, and protected
from rodent infestation.
Environmental Control
Humidity
Temperature
Dust
Interferences
17
Temperature Control
Temperature Recording

Temperature monitoring activities should be documented
Tolerance Limits

Established by determining the minimum range of values
common to the defined tolerance limits for reagents in
storage or the recommended incubation temperature for
the assays being performed
Temperature Review

18
Monthly review of temperature charts
Temperature Logs
Temperature records should include the following
information:
• Specific equipment being monitored for temperature
• Temperature values
• Date when the temperature was read
• Initials of laboratory personnel monitoring and recording
the temperature
• A section to record corrective action for out-of-range limits
• Space to record supervisor review signature and date
19
Temperature Logs (cont.)
20
Skill Check
You are required to store in the refrigerator reagent kits with
the following manufacturer recommended storage
temperature ranges:
ALT: 0°C to 8°C
 Pregnancy test: 2°C to 25°C

Rapid HIV: 3°C to 10°C
 Chemistry Controls: -10°C to 6°C

The optimal refrigerator temperature storage range would be
defined as:
A. 2°C to 8°C
B. 0°C to 25°C
C. 3°C to 8°C
D. 3°C to 10°C
E. 3°C to 6°C
F. 3°C to 10°C
21
Skill Check
The refrigerator where reagent test kits are stored malfunctioned
over the weekend. The laboratory personnel are not sure what to
do with all the refrigerator contents; they worry that if they discard
everything, huge losses would be incurred. How would you advise
them as the Laboratory Director?
A.
B.
C.
D.
E.
F.
22
Not to take a chance, but discard all contents
Mark affected materials to indicate possible quality problems
Continue using the reagents and kits as long as the QC is
acceptable
Perform parallel testing with new batches
Shorten the expiration dates of the reagents and kits
B and D
Skill Check
The following cannot be performed in the laboratory with a
defined ambient room temperature range of 16°C to 28°C:
A. 14°C to 28°C incubation temperature range for the
HBsAg Monolisa test
B. 2°C to 25°C storage temperature range of the
FACSCalibur reagents
C. 2°C to 27°C storage temperature range of the HIV
Determine kits
D. 25± 2°C incubation temperature range for the Vironostica
HIV EIA test
E. B, C and D
F. A and E
23
Equipment
Optimal working laboratory instrumentation is vital for:
24

Maintenance of productivity

Generation of accurate results

Lowering the incidents of equipment
malfunctions

Minimizing the costs of repairs

Reporting results in a timely manner
Equipment
Per DAIDS GCLP Guidelines, the laboratory should
maintain documentation to support that equipment is
properly:
25

Validated

Maintained

Operated

Tested

Inspected

Calibrated
Equipment Documentation
Scheduled Preventative
Maintenance
Unscheduled
Maintenance
Service
Calibration
26
Equipment Management
Monitoring of equipment management activities through:
Training and evaluation of competency
Review of maintenance, service, calibration, and QC
records
Review of procedures and updating, as required
Ensuring compliance with documented procedures
27
Preventive Maintenance/Calibration Plan
28

An equipment service schedule should be maintained

The list should include all equipment and the
accompanying due dates of service and calibration

Ideally, the equipment list should be displayed
Preventive Maintenance/Calibration Plan
29
Pipettes
Adjustable and Fixed-volume
Frequency of checks for accuracy and precision:
30

Before placing into service

Minimally, every six months
Refrigerators and Freezers
31

Establish maintenance
program

Establish tolerance limits

Monitor temperature

Check for ice build-up
regularly

Document corrective action
for equipment failures

Establish backup plan for
malfunctions
Incubators and Water Baths
32

Temperature tolerance limits

Periodic preventative maintenance

Temperature monitoring

Corrective Actions
Centrifuges
Equipped
with safety
buckets to
minimize
exposure to
aerosols
Centrifuges
Should be
kept clean
33
Adequately
maintained
(regular
service)
Centrifuges

Measurement of operating speeds, centrifugation
temperature and time
 Frequency
 Tolerance limits
34

Maintenance records

Corrective actions
Autoclaves
Verification of processing with each batch
Verification of sterilization weekly
Performance and documentation of maintenance
Verification of timing
35
Timers
Frequency
Known standard
36
Analytical Balances

Check accuracy with standard weights

37
Frequency determined by manufacturer

Service/maintenance performance and
documentation

Placement of balance
Analytical Balances
Design a balance calibration
verification log
38
Weight Verification Log
39
Biosafety Cabinets
Verification/
visual checks
Certification
before use and
annually
Daily air flow
checks
Cleaning
UV Lamp
Documentation
40
Microscopes
41

Cleaning of eyepiece,
objectives, stage,
condenser, and light source

Documentation of cleaning
activities

Scheduled service, where
applicable

Use of dust covers
Analyzers
42
Document a QC
program for the
analyzer
Maintenance
program developed
according to
manufacturer
specifications
All maintenance
activities should be
documented; review
preventive
maintenance (PM)
logs
Analyzer calibration
performed at
intervals specified
by manufacturer
Generators
Maintenance
and load
testing
Documentation
43
Skill Check
Select the best answer regarding laboratory equipment:
A.
B.
C.
D.
E.
44
Equipment SOPs may not be required if operator
manuals are available for use in the laboratory
Each equipment shall have an SOP that describes the
use, preventative maintenance, cleaning, and
calibration
The laboratory should maintain documented evidence
of personnel training for the use, operation, and
maintenance of all laboratory equipment
B and C only
All of the above
Equipment: Corrective Actions
How should failures and
corresponding
corrective/preventative
actions be captured?
45
Documentation of
the entire process:
failure through
resolution
Corrective Action Reports
46
Corrective Action Logs
47
Inventory
All laboratory equipment should be managed by an
inventory system.
Electronic
48
Manual
Equipment Inventory Log
Equipment make and model
Serial number; acquisition date
Facility ID number
Location
Disposition information
Service contact information
49
Skill Check
Can a biosafety cabinet certification sticker displayed on
the unit be used as a substitute for certification
documents?
A. YES
B. NO
50
Reagents
51
Reagent Labeling
Lot # and
expiration date
Contents
Adequate
labeling
Storage
requirements
52
Open
reconstitution
date
ID of staff
reconstituting
reagent
Certificates of Analysis
A document issued by the manufacturer confirming the
quality and composition of each batch and lot of
reagents, chemicals or media prepared
Therefore
Laboratories should obtain Certificates of Analysis
(COAs) with each new batch of critical reagents
purchased (cell culture media and solutions)
53
Certificates of Analysis
Should be
verified to check
the quality and
consistency of
purchased
media and
solutions
54
Describe specific
tests performed
to confirm the
quality of the
reagent lot
List tests
performed, the
tolerance, or
outcome allowed
for each test,
results of the tests
on a sample of
that lot, and lot
expiration date
Reagent Inventory
Uninterrupted availability of reagents and supplies:
Ensures laboratory
efficiency and cost
effectiveness
55
Prevents costly,
disruptive, and/or
wasteful steps that
hinder study progress
Inventory Control
Inventories
Make reagent
management
easier
56
Help in
identifying
expired
reagents
Help in
ordering
needs
Inventory Control
Determine
the method
Determine
the
frequency
Inventory
control policy
Monitoring
57
Skill Check
Choose the most true statement:
A. Expired reagents may be used if QC values are within
acceptable limits
B. The Laboratory may extend the expiration dates of
reagents and controls if QC is within acceptable range
C. Expired reagents required for use in training should be
labeled ‘EXPIRED – FOR TRAINING PURPOSES
ONLY’
D. None are true
58
Water
Policies

Schedules and methods for monitoring
water quality
Quality Checks

59
Document corrective action taken when
tolerance limits are exceeded
Remember…..
Whatever you do in the laboratory,
PLEASE
60
Post-Assessment Question #1
Which of the following are necessary for laboratory
facilities to ensure high standards of quality work, data and
safety?
A. Spills should be cleaned when convenient
B. Provide a safe environment for personnel
C. Proper lighting should be provided to ensure sufficient
visibility
D. A and B only
E. B and C only
F. A and C only
61
Post-Assessment Question #2
The following can occur in facilities with inadequate
laboratory space:
A.
B.
C.
D.
E.
F.
62
Frequent laboratory accidents
Increased incidences of specimen loss or mix-ups
Sub-optimal equipment performance
Likelihood of incorrect results being reported
All of the above
A and B only
Post-Assessment Question #3
Maintaining accurate laboratory equipment is important
for:
A.
B.
C.
D.
63
Generation of accurate results
Minimizing the costs of repair
Reporting results in a timely manner
All of the above
Post-Assessment Question #4
DAIDS GCLP requires that pipettes are checked for
volumetric accuracy and reproducibility and recalibrated at
what defined frequency?
A.
B.
C.
D.
64
Monthly
Annually
At minimum every 6 months
Every 2 months
Post-Assessment Question #5
Why is it important for clinical research laboratories to document
temperature monitoring and maintenance activities for laboratory
equipment, including calibration and QC testing?
A. It is a GCLP requirement
B. It ensures maintenance of an effective Quality Management
systems
C. It provides evidence of compliance to documented procedures
and policies
D. It assists in easy identification and corrections of problems
associated with inadequate performance of these activities
E. All of the above
F. A and B only
65
Post-Assessment Question #6
Which of the following are required for reagent labeling per
GCLP guidelines?
A.
B.
C.
D.
E.
F.
66
Lot number and expiration date
Open and reconstitution date
Date received from manufacturer
A and B
B and C
A and C
“Maintaining your equipment is
paramount in maintaining the
quality of your product.”
Frank Rabey
67
Wrap Up
68