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MONITORING CONTROLLED ENVIRONMENTS. Pacific BioLabs Inc. (510) 964-9000 info@PacificBioLabs.com. CONTROLLED AREA. Manufacturing area where non-sterile product and in process material contact equipment surfaces or are exposed to the environment

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monitoring controlled environments

MONITORING CONTROLLED ENVIRONMENTS

Pacific BioLabs Inc.

(510) 964-9000

info@PacificBioLabs.com

controlled area
CONTROLLED AREA
  • Manufacturing area where non-sterile product and in process material contact equipment surfaces or are exposed to the environment
  • Viable and nonviable contaminants are controlled to specific levels
  • Class 100,000 and Class 10,000
critical area
CRITICAL AREA
  • Aseptic processing area where sterile products/components are exposed to the environment and no further processing will occur
  • Class 100
building
BUILDING
  • Sufficient space to allow
    • proper cleaning, maintenance, and manufacturing functions
    • orderly operations
    • contamination control
  • Sealed windows, flush surfaces
  • Changing rooms/washing facilities
building cont
BUILDING (cont.)
  • Clean utilities such as gasses, water
  • HVAC system
  • Filtration of air – HEPA’s
  • Airflow from critical to less critical areas
  • Air lock to maintain positive pressure
environment hvac system validation
ENVIRONMENT/HVAC SYSTEM VALIDATION
  • HVAC air velocity, airflow patterns
  • HEPA filter integrity and efficiency
  • Air pressure differentials
    • 0.04 to 0.06 inches of water gauge
  • Cleaning and sanitization/disinfection studies
  • Airborne non-viable particle counts
  • Airborne viable particle counts
example www fda gov cdrh qsr 06bldng html
EXAMPLE (www.fda.gov/cdrh/qsr/06bldng.html)

Specifications for a medical device assembly facility

regulatory basis for environmental monitoring
REGULATORY BASIS FOR ENVIRONMENTAL MONITORING
  • CFR GMP regulations
  • FDA Guidance Documents
  • USP Informational Chapter <1116>
environmental control 21 cfr 820 70 c
ENVIRONMENTAL CONTROL21 CFR 820.70 (c)
  • “Where environmental conditions could reasonable be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions”
environmental monitoring components
ENVIRONMENTAL MONITORING COMPONENTS
  • Non-Viable Particles
    • Air
  • Microbial Contamination
    • Air
    • Surface
  • Pressure Differential
  • Water quality
  • Temperature and Humidity
product bioburden
PRODUCT BIOBURDEN
  • Does not have to be part of an environmental monitoring program
  • Test performed on a non-sterile product to determine its microbial load
  • Reflects the quality control of manufacturing process and raw materials
  • Needed to verify adequacy of sterilization process
environmental control 21 cfr 820 70 c14
ENVIRONMENTAL CONTROL21 CFR 820.70 (c)
  • An uncontrolled environment may result in inconsistent bioburden levels
  • Bioburden spikes may exceed the sterilization process capability to achieve the desired SAL
microbial identification
MICROBIAL IDENTIFICATION
  • USP <1116>
    • An environmental monitoring program should include identification of the flora obtained from sampling.
  • ANSI/AAMI/ISO TIR 15843:2000
    • Characterization of bioburden is required to reduce the frequency of dose audits
environmental monitoring program
ENVIRONMENTAL MONITORING PROGRAM
  • Documented in SOP
  • Details procedures used for monitoring
  • Includes sampling sites
  • Specifies sampling frequency
  • Describe investigation when Alert or Action levels are exceeded
  • Describes methods for trend analysis
  • Training
airborne particulate count
AIRBORNE PARTICULATE COUNT
  • AKA total particulate count
  • Detection of particles > 0.5 µm (outside of US particles > 5.0 µm are counted)
  • Monitoring is recommended during operations
  • Optical particle counting equipment is commonly used
microbial monitoring
MICROBIAL MONITORING
  • Assess the effectiveness of sanitization practices and of personnel
  • Provides sufficient information to ascertain that the environment is controlled
  • Is conducted during normal operations
microbial monitoring19
MICROBIAL MONITORING
  • Room air
  • Compressor air
  • Surfaces
    • Equipment
    • Sanitization containers
    • Floors
    • Walls
    • Personnel garments
airborne viable particulate count methods
Airborne Viable Particulate Count- Methods
  • Passive monitoring
    • Settling plates
    • Not generally recommended in US
  • Active monitoring
    • Solid culture medium impaction
    • Testing of known volumes of air that allow quantification by unit of volume air
airborne viable particulate count equipment
AIRBORNE VIABLE PARTICULATE COUNT - EQUIPMENT
  • Passive air monitoring
    • Petri dish with agar
  • Active air monitoring
    • Slit-to-Agar (STA)
    • Sieve Impactors
    • Centrifugal Impactors
    • Filtration
    • Liquid Impingement
    • Gelatin Filter Sampler
surface microbial monitoring methods
SURFACE MICROBIAL MONITORING METHODS
  • Contact Plates
  • Flexible Films
  • Swabs
  • Surface Rinse Methods
personnel monitoring
PERSONNEL MONITORING
  • Garments
    • Chest
    • Sleeves
    • Other areas are sampled for qualification
  • Gloves
    • Finger impressions
training program
TRAINING PROGRAM
  • Personal hygiene/habits
  • Illness
  • Clothing/gowning practices
  • Introduction to microbiology
  • GMPs
  • Introduction to aseptic techniques
  • Participation in media fills to demonstrate aseptic skill level
  • Must be documented
alert and action levels
ALERT AND ACTION LEVELS
  • Alert Level
    • A level than when exceeded indicates a process may have drifted from its normal operating condition. Warning that does not warrant a corrective action
  • Action Level
    • A level than when exceeded indicates a process has drifted from its normal operating condition. Documented investigation and corrective action required
action level investigations
ACTION LEVEL INVESTIGATIONS
  • Review of:
    • Maintenance records
    • Sanitization documentation
    • Operational parameters
  • Identification of microbial contaminants
  • Training of personnel
corrective actions
CORRECTIVE ACTIONS
  • Training of personnel
  • Additional sampling
  • Increased frequency of sampling
  • Additional sanitization
  • Additional product testing
  • Evaluation of the need to revise SOPs
  • Product impact/disposition documented
environmental monitoring surveillance support
ENVIRONMENTAL MONITORINGSURVEILLANCE SUPPORT
  • Alert and Action Levels
  • Data Management
    • Collection, trend analysis and interpretation
  • Isolates Characterization
  • Investigation/Corrective Actions
  • Documentation
references
REFERENCES
  • “Fundamentals of Environmental Monitoring”, Supplement TR 13, PDA J. Pharm. Sci. & Tech. 55(6), 2001.
  • United Stated Pharmacopeia 30, <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments. The United States Pharmacopeia Convention Inc., Rockville, MD. pp 589-596 (2007).
  • United Stated Pharmacopeia 30, <797> Pharmaceutical Compunding-Sterile Preparations. The United States Pharmacopeia Convention Inc., Rockville, MD. pp 334-351 (2007).
  • United States Food and Drug Administration “Medical Device Quality Systems Manual” (January 1997).
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