Microbiology and Analytical Sciences Capabilities

At 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.
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Microbiology, Environmental Monitoring, and Personnel Monitoring

Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) services include Contamination Control Strategy, Disinfectant Efficacy Testing, Environmental Monitoring Performance Qualification (EMPQ), Environmental Monitoring (EM) site selection and trending, Aseptic Process Simulation (media fill), Bioburden, Endotoxin, and more.
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Laboratory Design and Setup

Kymanox offers design, setup, and optimization support of analytical laboratories.
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Method Characterization and Validation

The Kymanox microbiology and analytical sciences team can assist with oversight and execution support for analytical method characterization, development, validation and transfer.
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Equipment and Instrumentation Selection

Kymanox can assist with lab instrument selection and qualification to ensure your environment is compliant and ready when you are.
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Other Areas of Expertise

Out Of Specification (OOS) Investigation, Laboratory Equipment Qualification, Method Transfer/Validation, Phase Appropriate Standard Operating Procedures (SOPs) and Test Methods, Elemental Impurities Assessment, and Raw Material Qualification
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EU GMP Annex 1

The Kymanox Microbiology and Analytical Sciences team provides knowledge and expertise to ensure that you align your practices to the revised European Union (EU) GMP Annex 1, a guidance document for the manufacture of sterile medicinal products.

What is EU GMP Annex 1?

EU GMP Annex 1 is a guidance document for the manufacture of sterile medicinal products that was recently revised and published on 25 August, 2022. Even if you currently do not have product approved by the EU, US FDA leaders have already indicated a desire to align with these standards. Adhering to Annex 1 requirements can help you improve product quality and reduce time and resources spent on remediating sterility and contamination-related issues.

Kymanox Expertise

Kymanox has expertise in aseptic processing, microbiology, environmental monitoring, and contamination control, making us uniquely positioned to succeed in helping our clients adhere to the revised Annex 1 requirements for the manufacturing of sterile medicinal products. Kymanox can help carry out risk assessments, assess root cause behaviors, establish an effective Corrective and Preventive Action (CAPA) system, set-up investigation procedures, and update procedures in the case of arising issues.

Contamination Control

The Kymanox microbiology and analytical sciences experts help our clients identify and close gaps to align with the revised Annex 1 and ensure that their processes minimize contamination-related risk. We can help author a document to outline the necessary policies and procedures for contamination control, develop and implement training on the new guidelines of Annex 1, and help implement smarter testing with documented risk-based sample plans that can improve efficiencies without sacrificing quality.

Frequently Asked CGxP Microbiology & Analytical Sciences 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. 
Is heavy metals testing still a requirement for Drug Product?
No. Heavy Metals testing has been replaced with USP <232> and <233> Elemental Impurities and ICH Q3D Elemental Impurities. Companies must comply with ICH Q3D and assess elemental impurities to develop risk mitigation for those elements that do not provide a therapeutic benefit.  An Elemental Impurities Risk Assessment can be used to evaluate all potential sources of elemental impurities and their contribution to drug product. Learn more at Elemental Impurities | FDA 
How is the reliability of raw materials used in cGMP manufacturing best achieved?
It is critical to control the raw materials used in the manufacturing process by qualifying the suppliers of the raw materials.  Without qualification, assurance in the safety, quality, identity, purity, and potency of the final product can be impacted.  However, it is often not necessary to perform full Certificate of Analysis testing for every raw material upon receipt. A risk assessment can be used to evaluate the required grade/purity of the material, the criticality of the raw material to the process, the applicable compendia, etc. to determine the appropriate level of raw material testing upon receipt as well as the frequency of requalification. 
Are in-use stability studies required for non-preserved products?
There is a regulatory expectation for non-preserved products that will be prepared, stored and punctured multiple times following release of the product to the clinic or hospital have an in-use stability study to support the use and storage of the product over a defined amount of time. In-use stability studies provide supporting data on the impact of sample manipulation, multiple punctures, storage temperatures, and duration of use for the product.  
Can Kymanox help with the selection and setup of my laboratory instrumentation and equipment?
Absolutely! The Kymanox Analytical Sciences group has professionals with global experience working with a vast array of laboratory instrumentation and equipment from bench-scale to commercial-scale in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide on-going support for all phases of development, from discovery to post-commercialization, with services ranging from research and selection of instrumentation/equipment that are best suited to your project needs, setup and qualification of instrumentation/equipment intended for GxP use, as well as troubleshooting issues with system performance and/or assay optimization.

The Kymanox Microbiology and Analytical Sciences 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!
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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.
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“Right First Time” Execution

Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
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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.
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