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)
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