CLEANROOM CERTIFICATIONS
ENVIRONMENTAL MONITORING
DIY - ENVIRONMENTAL MONITORING KITS
CLEANROOM CLEANING
EQUIPMENT VALIDATIONS

 

 

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 TESTING SERVICES CONSULTING

 

CLEANROOM CERTIFICATIONS - ISO 14644, Fed Std-209E, USP <1116>, NEBB

*We are ISO Certified

• Cleanroom Design, Installation, & Operations
• IQ/OQ/PQ Protocol development and execution
• Filter Leak Testing, Repair, Balancing & Replacement
• Compressed Dry Air (CDA) Testing
• Microbiological Sampling & Analysis
• Clean Bench Services
• Airflow Parallelism & Pattern Studies
• Standard Operating Procedure Development & Support
• Biological Safety Cabinet Services
• Laboratory Fume Hood Certification and Services

ENVIRONMENTAL MONITORING - ISO 14644, Fed Std-209E, USP <1116>

* ON-SITE Service is only available in Northern California

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 and supplies).
• Routine shift/monthly/quarterly/weekly 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.

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.

MicroMed can also characterize and identify your bacterial or fungal contaminants associated with on-site Environmental Monitoring should a contamination occur.

DIY - ENVIRONMENTAL MONITORING KITS - ISO 14644, Fed Std-209E, USP <1116>

We will help you develop an Environmental Monitoring plan for your cleanroom or controlled environment room and send you a kit to collect your microbial samples. 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. After collection you can mail the media plates back to MicroMed Labs for incubation and enumeration. Once finished we will mail you a report with analysis of the samples. 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.

MicroMed can also characterize and identify your bacterial or fungal contaminants associated with your Environmental Monitoring should a contamination occur.

CLEANROOM CLEANING

*We are ISO Certified

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

EQUIPMENT VALIDATIONS

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

 

SAVE MONEY ON CLEANROOM PRODUCTS

Buy Mops

Buy Particle Counters

Buy Gloves

Buy Pressure Monitors

Download Sample Submission Form (PDF)

Download Sample Submission Form (Word Doc)

pdfHow To Submit Your Sample Submission Form (PDF)

Download Test Index (PDF)

 

BSI Registered

ISO Certificate
(PDF)