IACUC

Occupational Health & Safety Programs

©
Occupational Health and Safety: Overview
Goals of a Health and Safety Program
Prevention of injuries and accidents through
• Elimination
• Avoidance
• Control of Hazards

©
Occupational Health and Safety: Overview
Methods
Protocol Review
• Risk Assessment
• Standard Operating Procedures
• Training
• Accident/Incident Reporting and Investigation

©
Methods: Protocol Review
• Risk Assessment

• Standard Operating Procedures

• Training

• Accident/Incident Reporting and Investigation

©
Methods: Protocol Review
Identify Hazards
• Risk Assessment • Chemical- flammables corrosives toxins
• Physical- noise  electrical radiation
• Standard Operating Procedures • Animal- zoonosis allergy infectious
• Biological- rDNA infectious/pathogenic

• Training

• Accident/Incident Reporting and Investigation

©
Methods: Protocol Review
Designate Hazard Controls
• Risk Assessment
1. Elimination or Substitution
2. Engineering/Facility Design
3. Administrative
• Standard Operating Procedures 4. Personal Protective Equipment

• Training

• Accident/Incident Reporting and Investigation

©
Methods: Protocol Review
Topics:
•
• Risk Assessment •
Hazards/Diseases
Signs/Symptoms of Exposure
• Chemical Hygiene
• Biosafety
• Standard Operating Procedures • SOP’s
• Waste
• Occupational Hygiene
• Emergency Procedures
• Training

• Accident/Incident Reporting and Investigation

©
Methods: Protocol Review
• Risk Assessment

• Standard Operating Procedures

• Training

• Accident/Incident Reporting and Investigation

©
Resources
• University of Scranton
• Chemical Hygiene Plan
• Biosafety Plan

• National Research Council

• Occupational Health & Safety in the Care & Use of Research Animals

• U.S. Centers for Disease Control and Prevention

• Biosafety in Microbiology and Biomedical Laboratories (5th Edition, 2007)

©
Contact
Health and Safety Office

x4277
x7888
University Police Department

healthandsafety@scranton.edu

©
Infection, Prevention
and Control
Learning Outcomes
• Know how individuals can contribute to infection prevention and control
• Have knowledge of and demonstrate the standard infection prevention
and control precautions relevant to your role. This may include:
Hand Hygiene
Personal Protective Equipment (PPE)
Management of Blood and Body Fluid Spillage
Management of Occupational Exposure (including sharps)
Management of the Environment
Management of Care Equipment.
Covid-19 Outbreak
Please note the information in this presentation gives guidance on
standard procedures.

Due to the Covid-19 outbreak, guidance is changing continually

therefore please read the Covid-19 Daily Briefing and the Covid-19
Information Hub for up to date Infection Control guidance.
Introduction
Infection Prevention and Control Is expected to be at the heart of good
management and clinical practice, to ensure effective protection of the
public’s health and minimise the risk of healthcare associated infections
(HCAIs). Effective prevention and control must be embedded into everyday
practice and applied consistently by everyone. All staff, both clinical and non-
clinical, must be able to demonstrate good infection control and hygiene
practice.
Patients and their relatives rightfully expect care to be delivered in an
environment where risks are proactively reduced and the control of
healthcare associated infection is recognised in all areas of the Trust to an
important aspect in the provision of care. This can only happen if all staff
accept responsibility for their role in ensuring good infection control practice
is adhered to at all times.
The Chain of Infection

To prevent the spread of

infection, break any one of the
links in the chain.
 Hand Hygiene

5 Moments for Hand Hygiene

• Before patient contact

• Before aseptic task
• After body fluid exposure risk
• After patient contact
• After contact with patient zone
 Required Method

PLEASE NOTE
Currently staff giving direct
care are required to include
washing arms up to the
elbows.
Bare Below the Elbows….
Hand hygiene is the most important method of preventing the spread of
infection.

All staff will need to comply with "BBTE" principles when providing direct
clinical care to patients or touching the immediate patient environment

Any staff who do not work in a clinical environment, but may need to enter
the patient environment as part of their role, will need to have the ability to
be Bare Below the Elbow and comply on these occasions.
Personal Protective Equipment
• May include the following (task dependent):

• Gloves
• Aprons Remember to check the
• Masks latest guidance on the
• Eye / Face Protection Covid-19 Daily Brief
• Oversuits

Single use only

 Decontamination

• Follow cleaning schedules – these must be displayed and go into

good level of detail

• Clean equipment regularly with appropriate products

i.e. beds, baths, hoists, commodes, bins, mattresses, computers, phones,
keyboards, reusable patient equipment

• Nobody is too posh to wash!

• Clean after use – stethoscopes etc

Management of Sharps

• Dispose of sharps immediately in the correct receptacle

• Safe assembly and use
• Report needlestick injuries immediately
• First aid – irrigate, bleed, cover
• Risk assess situation – Inform Occupational Health
0330 – 660 - 0365
• Complete an incident form
• Report near-misses – it’s how we learn
Waste
• Ensure waste segregated appropriately
• Household waste into black bags
• Infectious waste (dressings, blood etc) into orange bags
• Incontinence and sanitary waste into Tiger striped bags
• Only fill waste bags to 3/4s full and ensure they are secured
• Keep bins clean
Laundry

• Sort soiled linen streams

• Dirty – Clean streams
• Use alginet bags
• Storage of clean laundry
• Remember PPE
• Laundering of uniforms/work gear –
wash at 60o
• No unofficial restrooms
If you have any questions please contact:
katie.grayson@shsc.nhs.uk
jill.perlstrom-wright@shsc.nhs.uk

Thankyou
Environmental Monitoring
Considerations
Environmental Monitoring Components

• Airborne nonviable particulate monitoring

• Airborne viable contaminant monitoring
• Viable contaminant monitoring of surfaces
• Viable contaminant monitoring of personnel
• Temperature and humidity monitoring
• Pressure differential monitoring
Environmental Monitoring Components

• Water monitoring:
• Total organic carbon
• Conductivity
• Microbial Contaminants
• Endotoxin
General Environmental Monitoring
Considerations
• Monitoring frequencies and strategies
• Establishment of a meaningful and manageable
program
• Sampling and testing procedures
• Establishment of effective alert and action limits
• Trending of results
General Environmental Monitoring
Considerations
• Investigation and evaluation of trends as well as
excursions from alert and action limits
• Corrective actions to be implemented in response
to environmental monitoring excursions
• Personnel training - sampling, testing, investigating
excursions, aseptic technique
Scope of Environmental Monitoring Program

• Should include monitoring of all environments

where products and their components are
manufactured
• All areas where there is a risk of product contamination
• Should include monitoring of all water used for
product manufacturing as well as feed water to
the final water purification system (WFI System)
Regulatory Basis for Environmental Monitoring
Program
• CFR GMP regulations
• FDA Guidance Documents
• USP Informational Chapter
• Aseptic processing areas:
• Easy to clean and maintain
• Temperature and humidity controlled
• HEPA filtered air
• Environmental monitoring system
• Cleaning and disinfecting procedures
• Scheduled equipment maintenance and calibration
• Ventilation, air filtration, air heating and cooling:
• Adequate control over microorganisms, dust, humidity
and temperature.
• Air filtration systems including prefilters and particulate
matter air filters for air supplies to production areas.
Guideline on Sterile Drug Products Produced by
Aseptic Processing
• Defines critical and controlled manufacturing areas
• Recommends airborne nonviable and viable
contaminant limits
• Provides some guidance on monitoring
frequencies for critical areas
Guideline on Sterile Drug Products Produced by
Aseptic Processing
• Recommendations for air pressure differentials
• Includes guidance on aseptic media fills
• Note: This guidance document was written in 1987
and is in need of revision
Microbial Evaluation and Classification of Clean Rooms
and Clean Zones

• USP General Information Chapter <1116>

• Establishment of clean room classifications
• Federal Standard 209E
• Importance of EM program
• Personnel training in aseptic processing
• Establishment of sampling plans and sites
• suggested sampling frequencies
Microbial Evaluation and Classification of Clean Rooms
and Clean Zones

• Establishment of alert and action limits

• Suggests limits for airborne, surface and personnel
contaminant levels.
• Methods and equipment for sampling
• Identification of isolates
• Aseptic media fills
• Emerging technologies - barrier; isolator
Federal Standard 209E

• “Airborne Particulate Cleanliness Classes in Clean

Rooms and Clean Zones
• Approved by the GSA for use by all Federal
Agencies
• Frequently referenced for controlled environment
particulate requirements: Classes 100, 10,000 and
100,000 (based on particles > 0.5µ)
Guidance for Industry for Sterile Validation Process Validation
in Applications for Human and Veterinary Drug Products

• Scope limited to final drug product manufacturing

and data required for application submission
(NDA, BLA)
• Requests information on:
• Buildings and facilities
• Manufacturing operations for drug product
• Filter validation
• Validation of hold times
Guidance for Industry for Sterile Validation Process Validation
in Applications for Human and Veterinary Drug Products

• Requests information on:

• Sterilization and depyrogenation
• Media fills and actions taken when they fail
• Microbiological monitoring of the environment
• Airborne microorganisms, personnel, surfaces, water system,
product component bioburden
• Yeasts, molds, anaerobes
• Exceeded EM limits
Viable and Nonviable Contaminant Limits
Classifi- Nonviable (>0.5µ) Viable (CFU)
cation ft3 m3 ft3 m3
Class 100 3,530 0.1 3.5
100
Class 10,000 353,000 0.5 18
10,000
Class 100,000 3,530,000 2.5 88
100,000
Controlled Area

• Preparation or manufacturing area where

nonsterile product, in-process materials and
product-contact equipment surfaces, containers
and closures are exposed to the environment
• Control nonviable and viable contaminants to
reduce product /process bioburden
• Class 100,000 or Class 10,000
Controlled Area

• Capping areas are now considered controlled

manufacturing areas
• Should be supplied with HEPA filtered air
• Should meet class 100,000 conditions during static
conditions
Critical Area

• Aseptic processing area where sterile products,

components or in-process products are exposed to
the environment and no further processing will
occur.
• Air quality must be Class 100 during processing
• Local Class 100 areas are often utilized during
open processing steps during drug substance
manufacture.
Critical Area

• The area just preceding the sterile core should be

one classification higher than the core.
Nonviable Particulate Monitoring

• Airborne cleanliness classifications should be met

during operations
• Nonviable monitoring should occur routinely
during operations
• Monitoring during static conditions is done as part
of HVAC qualification and may be done
periodically after that to insure area meets
acceptable conditions before use or following
cleaning
Nonviable Particulate Monitoring

• Locations for monitoring should be established

during performance qualification; probes placed
close to work surface
• Monitoring frequencies vary:
• For aseptic processing areas, during each use
• For other, controlled areas, varies from each use to
weekly or less depending on use of area
Nonviable Particulate Monitoring

• HVAC Validation and Maintenance Considerations:

• Air velocity, airflow patterns and turbulence should be
validated; smoke studies to determine flow patterns
during static and dynamic conditions
• HEPA filter integrity testing
• HEPA filter efficiency testing
• Air pressure differentials
Microbial Monitoring

• Airborne viable contaminants

• Surface contaminants
• walls
• equipment surfaces
• countertops
• floors
• Personnel contaminants
Microbial Monitoring

• Monitoring methods should be capable of

detecting molds and yeasts
• Should also be able to detect anaerobes
• Most often, this is an issue associated with products
filled anaerobically (with nitrogen overlay)
• All lots of media for EM sampling should be
growth promotion tested
Microbial Monitoring

• Routine microbial monitoring should take place

during operations (for airborne contaminants) and
immediately following operations (for surfaces and
personnel).
• Airborne monitoring frequencies:
• Each use for aseptic processing areas
• Varies from daily to weekly to less frequently for
controlled areas depending on use
Microbial Monitoring

• Personnel and surface monitoring frequencies

vary:
• Aseptic processing - after every fill
• Other controlled areas - varies from daily to weekly or
less for surfaces
• Personnel monitoring often restricted to aseptic area
personnel and personnel working in Class 100 hoods
performing tasks such as inoculation
Microbial Monitoring

• Monitoring of surfaces and airborne contaminants

during rest periods (following cleaning)
• Important for confirming adequacy of cleaning
procedures
• Indicates whether HVAC system is operating properly
• NOTE: Disinfectant effectiveness studies also required
for cleaning agents used in the facility
Microbial Monitoring

• Monitoring frequencies and procedures are

influenced by a number of factors:
• Stage of manufacturing
• “Open” or “closed” manufacturing step
• Single or multiple product manufacturing
Microbial Monitoring

• Establishment of monitoring locations should be

based on performance qualification studies during
dynamic conditions
• gridding study to determine worst case locations/most
meaningful locations
• Should also establish common flora - will aid in
investigations
Setting Alert and Action Limits

• Action limits (for the most part) have been

established in a variety of guidance documents
• Alert limits
• Lower than action limits
• Reflect actual historical results under normal
processing conditions
Exceeding Limits

• Alert limits are designed to provide some warning

that environmental quality is approaching action
limit and allow you time to correct.
• Exceeding alert limit triggers a warning response -
i.e., alert affected area personnel
• Exceeding multiple alerts - triggers action level
response
Exceeding Limits

• Action limit excursions require investigations

• Speciation of organism(s)
• Review batch records from date of excursion
• Review other recent EM data (trends)
• Review cleaning records
• Interview personnel
• Product impact - must quarantine until determined
Exceeding Limits

• Excursions from action limits require corrective

actions that may include:
• More rigorous or additional monitoring
• More rigorous cleaning
• Retraining of personnel
• Procedural changes - change to or addition of
disinfection procedures, for example
• HVAC maintenance
Investigations and Corrective Actions

• The investigation procedures to be followed

should be pre-established and included in SOPs
• Depending on the outcome of the investigation,
corrective actions should be pre-established to the
extent possible
Investigations and Corrective Actions

• Imperative that EM results be linked to product

release so that affected products are not released
until investigation completed
• Material Review Board or equivalent should be
consulted prior to releasing product that was
potentially affected by adverse environmental
conditions
Trending

• Should trend monitoring results (environmental

and water)
• Periodic (quarterly or monthly) review by QA and
others
• Re-evaluation of action and alert limits on an annual
basis
• This trending information is generally included in the
Annual Product Review
Temperature and Humidity

• Control of temperature and humidity required for

aseptic processing areas
• 21 CFR 211.42(c)(10)(ii)
• Generally 65°F and 35-50% humidity are average
• Too high - Increases personnel shedding
• Too low - Increase static electricity
Temperature and Humidity

• Temperature should be controlled throughout all

manufacturing areas
• Temperature and humidity should be monitored
and controlled in warehouse areas where
temperature/humidity sensitive raw materials are
stored
• If not able to control humidity, need procedure to
follow if humidity exceeds limit
Water Requirements
Test Potable Purified WFI
Water Water
TOC none 500 ppb 500 ppb
Conduc- none See USP Table
tivity
Micro. 500 100 10 CFU/
Purity CFU/ml CFU/ml 100 ml
Endo- none none 0.25
Toxin EU/ml
Water For Injection

• Defined by USP
• Water purified by distillation or reverse osmosis
• Prepared from water complying with the U.S. EPA
National Primary Drinking Water Regulations
• Contains no added substance
Purified Water

• Defined in USP
• Obtained by a suitable process, usually one of the
following:
• deionization
• reverse osmosis
• combination
Potable Water

• Meets National Drinking Water Regulations

• 40 CFR Part 141
• Periodic monitoring in-house as well as periodic
certificates from municipality (if applicable)
Water System Monitoring

• WFI Systems
• Microbial quality and endotoxin
• Daily system monitoring
• Each use point at least weekly
• TOC and Conductivity
• Weekly system monitoring
• can be taken from worst case point (end of loop, return to
tank)
Water System Monitoring

• Purified Water Systems

• Weekly monitoring of system for:
• microbial quality
• TOC
• conductivity
Water Use

• WFI
• Solvent for preparation of parenteral solutions
• Formulation of mammalian cell culture media
• Formulation of purification buffers
• Final product formulation
• Vial and stopper washing
• Final rinse for product equipment
Water Use

• Purified Water
• Preparation of terminally sterilized microbiological
media
• Initial rinsing/cleaning
• Laboratory use
• Feed for WFI system
Water Use

• Potable Water
• Non-product contact uses
• Feed for purified water system
Microbial Monitoring Devices

• Slit-to-Agar (STA) - Powered by vacuum, air taken

in through a slit below which is a slowly revolving
plate.
• Sieve impactor - Vacuum draws in air through
perforated cover which is impacted onto petri dish
containing nutrient agar
Microbial Monitoring Devices

• Centrifugal Sampler - consists of a propeller that

pulls a known volume of air into the unit and then
propels the air outward to impact on a nutrient
agar strip
• Sterilizable Microbiological Atrium (SMA)- similar
to sieve impactor; cover contains uniformly spaced
orifices; vacuum draws in air which is impacted on
agar plate
Microbial Monitoring Devices

• Surface Air System Sampler - An integrated unit

containing an entry section with an agar contact
plate; behind is a motor and turbine that pulls air
in through the perforated cover and exhausts it
beyond the motor.
• Settle plates - qualitative; may be useful in worst
case locations
Microbial Monitoring Devices

• Surface contaminant monitoring devices:

• Contact Plates - plates filled with nutrient agar; for
regular surfaces
• Swabs - useful for hard to reach or irregular surfaces;
swab placed in suitable diluent and inoculated onto
microbiological plate
Monitoring Considerations

• Remote sampling probes - validate use of tubing

• Must sample adequate quantity of air to be
statistically meaningful.
• 80-100 ft3/min
• Must validate growth promotion after exposure of
settle plates (or other plates) for prolonged time
periods.