Bioburden Contamination Control Plan in Sterile & non sterile Mfg.
Development of a contamination control plan is critical to the success of aseptic, terminal sterilization and non-sterile manufacturing site.
Microbiology can provide a team of consultants, each expert in planning and executing an effective contamination control plan to address potential issues in your sterile or non-sterile manufacturing site.
This plan can help provide a approach and rationale to one of the most frequently-cited area of GMP & Regulatory compliance.
Environmental Monitoring for Sterile and Non-sterile Manufacturing
Recent regulatory changes have resulted in some confusion in how to conduct compliant environmental monitoring programs which will also serve the business needs of the company. Developing expectations for those industries regulated fewer than 21 CFR 211 and 21 CFR 610/612 for aseptic manufacturing, terminal sterilization and nonsterile manufacturing are difficult enough. However, adding to this are concerns over compounding pharmacies (USP <795> and <797>) and 503B Outsourcing Facilities and you have a situation where regulators and industry are trying to sort out the best program for a given situation.
Let the experts of Microbiology help you develop your monitoring system to be defensible and appropriate to your facility needs.
Microbiology Laboratory Operations
Microbiology is where we began. Call on the Microbiology to assist in all training, corrective action, investigations and laboratory design questions.
Objectionable Organisms
There is a great deal of interest in the topic of "Micro Objectionable Organisms" in the regulated industries.
A central question in this topic is "how do you determine if an organism in your product is objectionable?" This has been a source of concern for years in the pharmaceutical and OTC sectors.
Now it is becoming a source of concern for cosmetics manufacturers, personal care products and even compounding pharmacies.
The Rockwell has several national experts in non-sterile Quality Control (QC) microbiology. Let us help you come to a focused policy on objectionable organisms and procedures to meet your business needs.
Alternate Microbiological Methods
The use of rapid microbiological methods is one that has been popular in conferences. However, this popularity in the speaking circuit has not been matched by popularity in proactice for pharma, OTC, personal care products or medical device manufacturers.
There are many contributing factors to this slow adoption, but chief among these an over-optimistic expectation for the capabilities and returns on the RMM investiment from a corporate perspective.
Let the experts at Rockwell , Inc. help you sort through the marketing hype of vendors and consultants alike to provide a pragmatic approach to APPROPRIATE MICROBIOLOGICAL METHODS to meet your business needs.
Expert Witness
Expert witnesses from Rockwell, Inc. are drawn from nationally recognized practioners with experience in the Pharmaceutical, Compounding Pharmacy, Biotech, OTC and personal care products industries. No matter the specifics of your situation, we have someone who can provide expert witness consultation.
Compounding Pharmacy Services
Compounding pharmacies have seen a great deal of regulatory attention lately with FDA embarking on an aggressive inspection schedule that is producing multiple 483 findings. Rockwell has several nationally recognized experts that can provide assistance to the pharmacy in meeting regulatory requirements with the understanding of business realities. We can assist with:
483 responses
Corrective actions
Preparation for the audit
Qualification of contract facilities to protect the pharmacist
Expert help to Preparation and execution of clean room area qualification protocols per the current regulatory guidelines.
Expert help to handle frailer of Aseptic process simulations (media fills)
Analytical Method validations of- Bioassays, Bacterial Endotoxin Test, Microbial Limit Tests, Sterility tests.
Qualifications for Steam Sterilizers, Dry Heat Sterilizers, Incubators, Refrigerators, Laminar air flow station, Bio Safety Hood.
Clean room Qualifications: Qualification of sterile manufacturing areas Validations for Disinfectants efficacy and Stability.
Validation to define usage validity of Microbiological media, Sterilized and Depyrogenated Glassware's, Accessories and Garments.
Validation of gowning procedures, bioburden recovery from surfaces in sterile areas, Stasis tests, Penicillinase activity, Cleaning validation, Bulk hold study etc.