When it comes to having environmental monitoring that you can trust, turn to the team at Sure-BioChem Laboratories, LLC. Our monitoring service provides microbiology support, advice, and training.
We are actively involved in analyzing environmental report trending and finding the root cause of issues where microbial levels are exceeded. Our support for this service covers knowledge of different testing methods, and the analyzing of environmental results. We can also provide support to regain control of environments when out-of-spec results are yielded or to simply maintain control of regulated environments.
Microbiology is a major component of pharmaceutical and medical device industries. A critical element of our company’s monitoring focuses on helping you adhere to the best industry standards. We provide you with extra assurance that any microbial irregularities can be immediately corrected and that state and federal regulations are maintained.
Microbial support is necessary for a variety of reasons.
Here are a few of them:
Advise on Changes in Policies and Procedures
Ensures a High Standard of GMP Is Adhered To
Support Corrective and Preventive Action Process
Improving the Standards of the Cleanroom and Personnel Awareness
Issues That May Arise within the Cleanroom
Experienced External Advice
Prepares Clients for Regulatory Body Audits
Provide Objective Evidence through a Written Report
Establishing a valid and comprehensive monitoring plan is crucial for your cleanroom and its products. For this, we support you with a number of monitoring support activities, including:
Establishing Alert and Action Limits
Establishing New Environmental Monitoring Plans
Interpretation of Results
Selection of Microbiological Sampling Method
Maintaining a Library of Microbial Organisms
Maintaining and Supporting Existing Plans
Supporting Investigations on Spec Result
Writing and Updating Current Environmental Monitoring Policies and Procedures
Contact us to hire our team to help you set up your chemical monitoring and environmental monitoring procedures.