Aseptic Packaging. Content Introduction What is Aseptic? Aseptic Packaging Advantages Limitations.
Understand the Evolving Regulations for Aseptic Cleaning and Environmental Monitoring
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Transcript of Understand the Evolving Regulations for Aseptic Cleaning and Environmental Monitoring
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IVT’s Contamination Control Week June 25-27, 2012
Boston, Massachusetts
Session 5 • Understand the Evolving Regulations for Aseptic Cleaning and
Environmental Monitoring
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For more information on aseptic cleaning and environmental monitoring, please visit www.ivtnetwork.com.
Use the promo code SLIDE1 for a 10% discount on a membership!
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CONTACT INFORMATION for Course Leader:
David Vincent, CEO Validation Technologies, Inc. San Diego, CA Office: 800-930-9222 Fax: 858-638-5532 Email: [email protected]
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Topics Addressed
§ Regulatory requirements & expectations § Potential sources and types of microbial
contamination § Implementation of microbial control
measures § Disinfection/Sanitization § Environmental monitoring
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Microbiological control is a regulatory requirement
Part 1:
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CFR 21- 211.113 (a)
Control of Microbiological Contamination Microbial “Appropriate written procedures, designed to prevent objectionable organisms in drug products not required to be sterile, shall be established.”
§ Control of bioburden § Absence of objectionable organisms
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WHAT IS CONTAMINATION?
§ There are two types of contamination. Non-viable (Particulate)
– Air Filtration – Materials shedding
Viable (Microbiological or Bioburden) – Molds – Bacteria – Viruses
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Viable Contaminants § Viruses § TSEs (transmissible Spongiform encephalopathies § Fungi § Bacterial § Pyrogens (Endotoxin) § Mycoplasma § Biological Based Components (DNA, foreign proteins,
etc.)
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NONVIABLE CONTAMINATION
§ This is any type of contamination that is not viable. It is usually filterable. For example: § Dirt, sand, powders, etc. § Particulate § Debris § Molding flash § Chemical contamination such as crystals, etc. § Oils and Mold Release agents § Insect parts
§ Controlled room classifications are defined by particulate contamination sizes and numbers.
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What is Contamination Control?
§ Contamination control is not simply a task or function. It is a science and applied technology that interacts continuously with all products, processes, materials, equipment, and personnel entering the manufacturing areas.
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Microbiological Control § Identify possible sources of
contamination § Identify possible types of contamination
likely to occur § Implement and validate/qualify
preventative and control measures
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Possible Sources of Contamination
§ Raw Materials/Excipients § Equipment and Process § Environment/Facility § Personnel
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Raw Materials/Excipients
§ Bioburden in raw materials and excipients v natural vs synthetic products v water activity level
§ Bioburden in water systems v potable water, purified water, WFI v biofilm
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Equipment and Process
§ Process and Equipment Design
§ Material/Surface § Unprotected storage tanks § Back flow § Perforated heat exchangers
§ Carbon filters/DI resins/membrane filters
§ Sampling/transfer hoses
§ Valves § Dead legs
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Facility § Facility design § Air handling system § Construction materials § Finish materials
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Personnel § Major potential source of microbial
contamination v Exposed skin (flakes, oils) v Hair v Clothing fibers v Dirt v Cosmetics v Tobacco smoke v Behavior
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Regulatory Expectations Related to Cleanroom Operations
Part 2:
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Facilities: Cleanroom Classification
FS209 Cleanroom
classification
ISO 14644-1 Cleanroom
classification≥0.5um
particles/m3
Viable Microbes(cfu/m3)
Ave Airflow Velocity
(fpm)Air
changes/hr
100,000 8 3,520,000 100 5-10 5-48
10,000 7 352,000 10 10-15 60-90
1000 6 35,200 7 25-40 150-240
100 5 3,520 1 40-80 240-480
§ a- All classifications based on data measured in the vicinity of exposed materials/articles during periods of activity.
§ b- ISO 14644-1 designations provide uniform particle concentration values for cleanrooms in multiple industries. An ISO 5 particle concentration is equal to Class 100 and approximately equals EU Grade A.
§ c- Values represent recommended levels of environmental quality. You may find it appropriate to establish alternate microbiological action levels due to the nature of the operation or method of analysis.
§ d- The additional use of settling plates is optional. § e- Samples from Class 100 (ISO 5) environments should normally yield no microbiological contaminants.
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Equipment and Process
§ CFR 211.63, “Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.”
§ Q7A, 5.15, “Closed or contained equipment should be
used whenever appropriate. Where open equipment is used, or equipment is opened, appropriate precautions should be taken to minimize the risk of contamination.”
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Equipment and Process
§ Equipment v easily disassembled and cleaned v use sanitary fittings and valves/avoid dead legs v product contact surfaces resistant to corrosion v store cleaned equipment in a sanitary condition
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Equipment and Process § Equipment flow and location
v no cross flow of clean and dirty and contaminated equipment/materials
§ Process
v evaluate each step in a process for the potential of microbial contamination
v use closed systems whenever possible v open operations should be contained within HEPA
stations
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Environment & Facility
§ Flooring and wall materials must be easily cleaned
§ Surfaces must be resistant to chemicals, abrasion, and flaking
§ Ensure concave coving at the junction of walls and floors
§ Floors must be sloped toward the drain § Clean/sanitize floors daily § Cover floor drains when not in use § Avoid standing water
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Environment & Facility § Evaluate traffic patterns and room capacity § Production and packaging areas need to be
under positive pressure § Establish and monitor operating parameters and
environmental controls § Use HEPA filtration systems § Clean up spills immediately § Cover air ducts, pipes, and light fixtures § Avoid build-up of dust and moisture
accumulation
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Cleaning and Disinfection
Part 3:
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Disinfection/Sanitization Program
• Cleaning/Sanitization is a regulatory requirement
• Cleaning should not be confused with disinfection
• A cleaning program is not complete without contamination control
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Disinfection/Sanitization Program
§ CFR211.56 (b) “ There shall be written procedures assigning
responsibilities for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.”
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Preparation and Use of Disinfectants
Preparation and Storage • EC Guide, Annex 1,
“Disinfectants and detergents should be monitored for microbial contamination: dilutions should be kept in previously cleaned containers and should only be stored for defined periods unless sterilised. Disinfectants and detergents used in grade A and B areas should be sterile prior to use.”
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Current regulatory expectations for use of disinfectants Rotation
• EC Guide, Annex 1, 37 “Where disinfectants are used, more than one type should be employed. Monitoring should be undertaken regularly in order to detect the development of resistant strains.”
• ISO Recommendation • Industry Practice
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Product Classification
§ Sanitizers v proper use results in 99.9% (3 log) reduction of bacteria v cannot handle soil; use on pre-cleaned surfaces
§ Disinfectants v proper use results in 100% (> 4 log) reduction of bacteria and
yeast. Limited reduction for mold. v most have surfactants/cleaning ability
§ Sterilants v proper use results in 100% (> 6-7 log) reduction of all
microorganisms, including bacterial spores. v require application on pre-cleaned surfaces
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Disinfection efficacy
§ Suitability, efficacy & limitations of disinfectant agents and procedures should be assessed.
§ The disinfection program should include the use of a sporicidal agent used according to a written schedule and when environmental data suggests presence of spore forming agents (Baccilus spp.).
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Endospores Mycobacteria
Fungal Spores Small Non-enveloped viruses (polio, rotavirus, rabies)
Vegetative Fungal Cells Enveloped Viruses (Herpes, Hepatitis B, Hepatitis C, HIV)
Vegetative Bacteria
Most Resistant
Least Resistant
Disinfectant Efficiency
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Equipment and bacteria
Even seemingly smooth surfaces can harbor bacteria !
Scanning electron micrograph of Listeria monocytogenes forming a biofilm in soy on a stainless steel chip. Courtesy of Professor Amy Wong.
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Cleaning/Sanitization Program An effective cleaning and sanitization
process is attained by: § Treatment with strong acids and bases § Use of high velocity hot water or steam § Use of detergents and/or sanitizers § Rinsing with high quality water (Purified or WFI) § Use of solvent rinses § Drying at elevated temperatures
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Disinfectant Selection
§ Population and types of organisms § Spectrum of activity of disinfectant § EPA registrations § Method of application § Contact time § Nature and surface to be disinfected § Compatibility of surface with disinfectant
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Disinfectant Selection
§ Corrosiveness of disinfectant § Organic compounds present on surface § Operator safety § Compatibility with cleaning agents § Planned rotation of disinfectants § Needed steps to avoid contamination of
pharmaceutical products by disinfectant § Need for residual bactericidal activity
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Disinfectant Selection - Other Factors to Consider
§ Quality, sterility, and stability of product § Ease of application § Cleaning ability § Supporting vendor documentation § Cost and availability § Factors that may affect performance (temp.,
organic matter, contact time, pH, etc…) § Regulatory expectations/regulations
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Current regulatory expectations for use of disinfectants § Disinfectants Qualification
v Studies to evaluate the effectiveness of the disinfectants as they are used and prepared
v Studies to evaluate the storage conditions of disinfectants for possible loss of efficacy
v Use of environmental isolates in the qualification studies
v Neutralization studies
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Disinfectant Qualification - Studies
In-Situ § Use actually cleaning procedures § Monitoring pre and post cleaning at worst-case conditions/
document activities § Increased number of sample sites § Compare EM data before & after
In-Vitro § Surface Tests (use of coupons or pieces of equipment/
material) § Carrier Tests (AOAC method) § Use-Dilution Tests (modified AET )
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Disinfectant Qualification - Studies
Typical Test Organisms § Escherichia coli - ATCC 8739 § Pseudomonas aeruginosa - ATCC 9027 § Staphylococcus aureus - ATCC 6538 § Bacillus subtilis - ATCC 6633 § Candida albicans - ATCC 10231 § Aspergillus niger - ATCC 16404 § Environmental isolates
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Disinfectant Qualification Surface Test
§ Preferred method by inspectors § No guidance document available § Must select types of surfaces (coupons) § Variable microbial challenge level § Quantitative method § Must select contact times (1-5-10 minutes) § Variable test conditions (wet vs dry) § Sampling/recovery technique (swab, rinse, contact
plate) § Need neutralization studies
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Disinfectant Qualification - User’s Approach/Decisions
§ Type of agent and materials/surfaces and sites to be evaluated.
§ Testing protocol (In-vitro vs In-situ) § Types of challenge organisms § Contact times § Sampling methods (swab, rinse, or contact
plate)
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Disinfectant Qualification - Acceptance Criteria
§ Surface Tests v ≥ 3-log reduction vegetative bacteria and fungi v ≥ 2-log reduction spore-forming bacteria
§ Use-Dilution Tests v ≥ 4-log reduction (disinfectant properties) v ≥ 6-log reduction (sporicidal properties)
§ Carrier Test v AOAC criteria
§ In-situ Test v counts not to exceed alert levels
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Environmental Monitoring Program
Part 4:
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Monitoring and Trending
§ Establish an EM program § Employee training and monitoring § Enforce personal hygiene § Enforce cGMPs § Schedule regular PMs § Product bioburden testing/trending § Re-qualification vs on-going verification of
cleaning (bioburden and endotoxin) § Change control
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EM Program § Regulatory requirement § Must be tailored to a facility § Must be manageable and efficient § Must be well documented § Must be defendable § Must not add possible sources of contamination
into the environment § Do not rely solely on EM data for assurance of
product quality
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EM Program
EM is a tool to assist a company manage the microbiological control program
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EM Program
Choice of Equipment § Active vs passive § Air and surface monitoring devices § Detection of potential problems must be
done in a timely manner § Sampling activities should not contribute to
contamination of the process
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EM Program
Test Methods § EM procedures must be qualified § Use same methods used during qualification studies § Viable and non-viable monitoring § Use of specific media for fungi: is it really needed? § Monitoring for anaerobes: is it really needed? § Levels are established based on industry guidelines
and/or historical data
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EM Program
Frequency and Sites § Depends on area being monitored § More intensive monitoring for “cleaner”
areas § Usually frequency is reduced once
qualification is complete § Trend towards continuous monitoring § Site selection: depends on room design,
activities, equipment and personnel flow
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EM Program
Data Management § Results are retrospective § Useful information can be obtained by trending
data § Evaluate data based on Alert and Action Levels § Identify isolates § Frequent isolates should be maintained and used
in challenge studies
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EM Program - Hot Topics
§ EM data linked to batch release EC Annex 1, 5 “Where aseptic operations are performed, monitoring should be frequent…Results from monitoring should be considered when reviewing batch documentation for finish product release…”
§ EM requirements for non-sterile operations
§ Use of PAT and Rapid Methods
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EM Program – Focus of Regulatory Inspections
§ Create presentation describing program v area classifications v methods v frequency v rationale for choice of sites v rationale for setting alert and action levels v describe data management and trending
§ Create trend reports for each area v tabular and graphical format v trend by values and organisms
§ Create executive summary reports v address deviations, adverse trends, CAPA
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Thank You!!