Consulting Services
Consulting Services
Medical Device Consulting Services
- ISO 11135: Ethylene Oxide (EO) Sterilization –
- ISO 11137: Electron beam (E-beam) Sterilization
- Vaporized Hydrogen Peroxide (VHP) Sterilization
- ISO 11137: Gamma Radiation Sterilization
- ISO 11737: Sterilization of Healthcare Products – Microbiological Methods
- ST58/ TIR12: Reprocessing of Reusable Medical Devices
- EN 17141: Cleanroom and Associated Controlled Environments – Biocontamination control
- Interpretation or liaison for Microbiology testing
- Provide Audit-Ready Support
Pharmacy/ Hospitals/ Sterile Compounding Consulting Services
- USP 797: Sterile Compounding
- USP 800: Hazardous Drug Handling in Healthcare Settings
- USP 71: Sterility Test
- USP 85: Bacterial Endotoxin
- EN 17141: Cleanroom and Associated Controlled Environments – Biocontamination control
Pharmaceutical/ ATMP / Biotechnology
- Annex 1: Manufacture of Sterile Products
- TR – 13: Fundamentals of an Environmental Monitoring Program
- USP 85: Bacterial Endotoxin
- USP 61/62
- TR – 90: Contamination Control Strategy
- EudraLex Volume 4
Custom Solutions for Your Lab and Facility
Microbiology Management Lab and Consulting provides its clients guidance and advice to remediate or improve their overall Microbiology and Quality Control program(s). We work remotely, on-site, or hybrid, depending on our clients’ needs. We work in a few disciplines, which provides us with the ability to draw from each other’s knowledge and apply it effectively. Microbiology Management can assist or manage your lab or facility startup as it pertains to microbiology. We can retroactively help develop risk assessments, CCS plans and Gap analysis that can withstand regulatory scrutiny.
MMLC President and Founder, Kiee Gates-Garland has extensive knowledge and experience functioning as a business microbiology expert liaison for audits. She has provided effective corrective action and continuous improvement plans that have met regulatory acceptance and benefited the company’s overall mission and goals.
Kiee has had vast experience in helping clients in the pharmacy and hospital world navigate through the challenges of USP 797 and USP 800 utilizing personal experience in working in clinical, pharmaceutical, biotech, aseptic processing, and ATMP environments.
She also has experience in leading and championing the implementation of current Annex 1 while assisting the current state of the quality system. Kiee provides consulting on how personnel should enter a clean/ controlled environment to exit the environment and all the steps in between.
