MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is ISO 9001:2000 certified and complies with U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.

Environmental Monitoring - ISO 14644, Fed Std-209E, USP <1116>

Cleanrooms and controlled environments are utilized in order to control the levels of non-viable and viable particulates that medical devices and pharmaceutical products are exposed to during the manufacturing process. The objective of an environmental monitoring program is to estimate the microbial and particulate content of room air and surfaces. An effective environmental monitoring program can alert you when conditions contributing to excessive microbial levels arise due to ineffective cleaning, sanitation or other personnel/equipment issues. MicroMed can provide you with the appropriate level of service that you need to ensure your manufacturing environment complies with FDA, USP and ISO requirements. We offer:

• Incubation and reporting of results (media, supplies and training are available if necessary).
• Routine shift/monthly/quarterly environmental monitoring by our expert technicians for our California Bay Area clients.
• Full validation including IQ, OQ, and PQ protocols and final reports to establish a sampling plan at appropriate sites, as well as determine appropriate alert or action levels for your manufacturing environment.
• Periodic reevaluation/reseting of Alert/Action levels and identification of prominent microorganisms.
• Alert/Action level failure analysis and planning.

Viable Air Monitoring - ISO 14644, Fed Std-209E, USP <1116>
A calibrated centrifugal air sampler is used to sample a defined volume of air, embedding viable particulates onto sterile media strips. The media strips are incubated to promote the growth of viable particulates, the microorganisms are enumerated and results are reported as the number of CFU (colony forming units) per volume of air sampled.

Surface Monitoring - ISO 14644, Fed Std-209E, USP <1116>
Contact plates filled with media are used to sample tabletops, walls, benches, floors, garments, and gowned personnel to measure the number of microorganisms per area sampled. The media contains a neutralizer which inactivates cleaning and disinfection solutions to ensure that any microorganisms present are not inhibited from growing. The plates are incubated to promote growth, the microorganisms are enumerated and results are reported as the number of CFU (colony forming units) per area sampled.

Passive Air Monitoring - ISO 14644, Fed Std-209E, USP <1116>
Settle plates filled with media are used to sample the microbial fallout over time. This type of sampling is qualitative and should not be used for quantitative estimations, but are good for sampling over longer periods of time and when used in conjunction with quantitative sampling methods. The plates are incubated to promote growth, the microorganisms are enumerated and results are reported as the number of CFU (colony forming units) per time sampled.

Non-Viable Particulate Monitoring - ISO 14644, Fed Std-209E, USP <1116>
A calibrated laser particle counter is used to sample a defined volume of air. The particle counter can measure a variety of particle sizes, most commonly 0.5 and 5.0 micron particles. Particle counts are recorded as the number of particles per volume of air sampled. Results can be reported per cubic foot, per FDSTD 209E, or per cubic meter, per ISO 14644. Note that FDSTD 209E has been retired and ISO 14644 is the current guidance that should be followed when developing a new Cleanroom environment. Regardless many companies still use FDSTD 209E.

Cleanroom/Controlled Environment Validation
Installation, Operation and Performance qualification protocols should be developed for controlled environments that establish the following:

• Proper operation of the controlled environment and supporting equipment
• Quantity and placement of sampling sites.
• Frequency of sampling.
• Microbiological and nonviable particle alert and action levels.

Cleanroom/Controlled Environment Modifications
Modifications to Cleanrooms/controlled environments should be evaluated to ensure the existing validation is still applicable. Addition of major components, expansion of the room and addition of more personnel and operations in the room can all affect the performance of the room. At the very least Alert and Action levels should be re-evaluated to ensure realistic cleanliness standards are kept within the room and sterilization validations do not become compromised.

Cleanroom Cleaning

• Pre-Certification Cleaning
• Baseline Testing
• Perform MicroCleaning
• Create Validation Program
• One time Project Clean
• On-going Contract Clean
• Post Construction Cleaning
• Process Equipment Cleaning

CLEANROOM/CER VALIDATIONS

• Cleanroom Design, Installation, & Operations
• Cleanroom Class Certification (ISO-14644, FS-209E)
• Facility Validations
• cGMP Calibrations
• Filter Leak Testing, Repair, Balancing & Replacement
• Compressed Dry Air (CDA) Testing
• Microbiological Sampling & Analysis
• Clean Bench Services
• Airflow Parallelism & Pattern Studies
• Light Level, Sound Level & Spectrum Testing
• Floor Conductivity Testing
• Standard Operating Procedure Development & Support
• Containment Services
• Environmental Health and Safety Services
• Biological Safety Cabinet Services
• Laboratory Fume Hood Certification and Services

EQUIPMENT VALIDATIONS

• Protocol Development and Execution (IQ,OQ,PQ)

CLEANROOM LEASING

• Class 100 Controlled Environment Room
• Class 100 Biological Safety Cabinet
• Sterile Gowning Supplies provided