On-Site and Soon in the Laboratory
Identification
Microbiology identification via gram staining and characterization, Phenotype and DNA identification, enumeration and correct calculation, and proper reporting. Kiee has previous experience starting, managing, and leading FDA or European-regulated/ complaint microbiology, chemistry labs and contract laboratories with novice staff and training and developing team members to be knowledgeable and skilled in the application and the science behind. She has led projects leading microbiology labs back into compliance and training and educating team members to be able to troubleshoot complex issues. We understand how to access the importance of the organism recovered whether for clinical purpose or the environment found in.
We have assisted countless clients and corrected misconceived results that did not match the phenotypic or genotypic results, helping to error proof the results. And guiding and educating client’s interpretation of the microbiology results and their meaning.
Viable and Total Particulate Air Sampling, Surface Sampling, and Neutralization
USP 797, Annex 1, ISO 17141, and a host of PDA Technical Reports guidance and standards have provided much understanding of the requirements and importance of environmental monitoring. We will assist you in the scientific reasoning and methodology for navigating this process to determine the risked-based randomized samples’ sites, measurements, and volumes to provide knowledge on what the results mean and what to do. It does not matter if you are an aseptic manufacturing, sterile compounding, terminal, or chemical sterilization company, we can help!
If your facility has gone “out of control” or “need a nudge or need help with the starting point, we can effectively! We provide training in the best understanding, and aseptic techniques to prevent sampling, personnel, environmental, training, and testing errors. We help train all personnel how to spot and prevent microbial deviations and preventable contamination blind spots. We take into consideration the operational/ active cleanroom where total particulate sampling may need allowance. Contact us to find out what these are.
Compressed Air/ Gas Sampling
ISO 8573 gas sampling provides directives on what to test to ensure the gases and compressed air are clean and without particulate matter. Many companies need help navigating whether to test in-house or utilize a contractor for testing. It’s also important to understand the Compressed air system and how the piping is designed. In small facilities, choosing a site may be easier; however, in mid-size or larger facilities, there may be over 50 to 100 possible sample points. We can assist in developing a risk assessment and map a plan on which sites would be most beneficial to understanding what would provide the best coverage to ensure control.
Effective and Best Applied Cleaning Practices
Annex 1 and USP 1072 provides directive on cleaning, disinfecting and sterilizing surfaces which can apply to tables, floors, ceiling and walls and BSC, Isolators or RABS devices. We can help you develop a risk based and cost plan if you are a start up company seeking to ensure your cleaning agents and materials are appropriate while determining the best controlled and repeatable cleaning manipulation that keeps your environment in control and your team members able to repeat consistently. We provide training in education, didactic and applied and comprehension assessments.
We can assist in developing the qualification of reprocessing for medical devices as per ISO 17664 and AAMI ST91 or help in the corrective action plan in a failure or regulatory notification.
Cleanroom Site Selection, Risk Assessment, CCS
Annex 1, USP 797, and ISO 17141 provides guidance or/ and directive on the necessity of developing a contamination control strategy. After collaborating with many companies that have implemented plans and checked all boxes, we have assisted or led companies in developing programs that meet regulatory requirements but also armor programs with forethought preventative causal issues. Many times, CCS is developed on a “high-level basis” we want to place an eagle eye on the entire process!
Media fill Simulation and Personnel Monitoring
USP 61, 71, and 797 regulatory guidance and directives all require contamination-free handling and manipulation. Whether sterile compounding or aseptic processing, there is a need for proper education and aseptic simulations. We can provide you with the best techniques and practices because of our experience in preparing, sampling, testing, and performing aseptic tasks, such as sterility testing, media filling, and product filling via filtration or aseptic practices. We can help provide you or your department with techniques to help personnel make their personal behavior and garbing practices become their involuntary aseptic and microbiology focus.
Water Collection and Testing
Water testing is a requirement per US Pharmacopeia and European Pharmacopoeia. Aseptic skills and the understanding of material interaction is necessary to evaluate your water to ensure valid results and test method for collection and testing of purified water, highly purified water, still water, RODI and Water for Injection. Additionally, there are many steps to collection and many types of testing. We can provide education on instrumentation basic and proficient troubleshooting issues and resolutions, including proper aseptic sampling and prevention. Although we are not a analytical microbiology lab and the moment we can provide experience in choosing instrumentation, IOPQ, transfer and implementation due to over 18 years of experience.