CGxP Microbiology & Environmental Monitoring Capabilities
The Kymanox Intelligent EnterpAt Kymanox, our risk-based approach to Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) ensures facilities and personnel operate in a state of control — ultimately ensuring patient safety. Our team is an international provider of ERP Optimization, Implementation and Compliance solutions for life sciences. We offer a unique patient-centric, risk-based approach balanced with both regulatory requirements and business needs.
01
PAI Readiness Gap Assessments
Kymanox offers PAI readiness gap assessments to ensure you’re aligned with regulatory guidelines and expectations. Our clients have a perfect track record when they address gaps identified in our assessment.
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02
Site, Equipment, and Instrument Selection
Routine EM Site Selection, Justification, and EM Trend Reports, as well as Lab Instrument Selection and Qualification to ensure your environment is compliant and ready when you are.
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03
Risk-Based Approach
We provide a wide-range of services including: Out-of-Specification (OOS) and Root Cause Investigation, Corrective and Preventative Action (CAPA) Closure, Rapid Sterility and Alternative Endotoxin Methods, and more.
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Meet our CGxP Microbiology & Environmental Monitoring Experts
Jaime Rain
ASSOCIATE DIRECTOR, QUALITY CONTROL
Markets That Benefit from Our CGxP Microbiology & Environmental Monitoring Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics
We understand why “the product is the process” and how to implement solutions to your unique challenges.
The Kymanox CGxP Microbiology & Environmental Monitoring Difference
At Kymanox, we tailor our services for each unique client and each unique project. Combined with our broad expertise across functions our solutions help you Get More Done!
Phase Appropriate EM & PM Support
We provide support to implement phase appropriate Environmental and Personnel Monitoring and Microbiological testing for clients anywhere from Phase I development to full commercialization.
“Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
Unmatched Expertise
We provide expertise for products that range from medical devices and non sterile products, to sterile parenterals. No matter your challenge, we can help you conquer it.
What Our Clients Have To Say About Kymanox
Frequently Asked CGxP Microbiology & Environmental Monitoring Questions (FAQs
How should a company establish Environmental Monitoring action and alert levels?
Action Levels should be set at or slightly below compendial/regulatory levels. However, there are no regulatory guidelines regarding alert level calculations. Because EM data is not normally distributed, using the data average plus 2 standard deviations is typically not the best approach. The Cutoff Value Approach is recommended in evaluating and establishing alert levels. Whichever approach is used the levels need to be based on historical data and the justification document.
Should predominant environmental (in house) isolates be used in the execution of microbiology method verifications?
Absolutely! It is necessary to use USP challenge organisms during the execution of method verifications. However, the use of predominant isolates recovered internally from the manufacturing environment in method verification protocols demonstrate that in the event the predominant isolate is present in the product, it can be recovered and detected using the compendial test method.
Which disinfectants should be used in manufacturing and is disinfectant efficacy testing a ‘one time’ protocol?
The selection of disinfectants used in the manufacturing environment depends on the object to be disinfected (entire room or specific surfaces), the classification of the room, expected bioload, the contact time, possible contamination of the drug product and on the most suitable disinfectant process (wiping vs. spraying, disinfectant concentration, etc.). Disinfectant efficacy testing of general-use disinfectants is performed using vegetative bacteria. Sporicidal disinfectants are challenged with spore-forming bacteria. Disinfectant efficacy testing may need to be repeated after major modifications or changes to controlled areas that may impact the validity of testing. These changes include, but are not limited to:
- The introduction of a new disinfectant or cleaning method
- Changes in the formulation or storage times of a disinfectant
- The use of new surface materials
- Adverse trends in isolates recovered from routine environmental monitoring.
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