A well-developed Environmental Monitoring Program is a proactive way to assure the cleanliness of the manufacturing facility or clean room is maintained.
C.G. Laboratories, Inc. offers the following types of Environmental Monitoring to serve your various needs.
Air monitoring is vital in medical device manufacturing. Allow C.G. Laboratories, Inc. to assist you with your environmental compliance. C.G. Laboratories, Inc. utilizes an RCS Biotest air sampler. This instrument allows an environmental technician to sample all airborne microbes in a particular area. This unit is capable of sampling in cubic feet of air. After incubation, the number of microbes can be calculated in a cubic foot of air with supreme accuracy. The microbes isolated from the air can then be identified if desired.
C.G. Laboratories, Inc. also offers Air Settling Plates for viable air monitoring that can be purchased, incubated, enumerated, reported and identified if desired.
C.G. Laboratories, Inc. utilizes a Met One laser particle counter. This instrument tests all the non-viable particles in the air at the sample site, i.e. dust. This unit is capable of testing 0.3 micron to 5 micron particulates in a cubic foot of air and calculated to cubic meter of air.
Both RODAC and Contact Slides are used to determine viable micro organisms on critical surface areas and also on key personnel.
If your sampling location is out of reach for our technician to sample your air, call and we can help you find other ways to monitor your air quality including rental of our equipment.
Frequency of monitoring depends on product and quality requirements. Sampling frequency may be subject to change depending on trending analysis and changes in equipment, processing or number of personnel in a qualified area. A sampling plan describing procedures and identifying sample sites, sampling numbers and sample frequency can be developed with proper documentation in order to demonstrate that there is a constant level of control over the environment within the clean room facilities.
These areas include clean-rooms for drug fill/finish, formulation tank rooms, laminar flow hoods, biological safety hoods, isolators, glove boxes, molding machines, kit assembly lines, Intravenous (IV) compounding areas and sterile and non-sterile packaging. CG Laboratories specializes in Environmental Monitoring of both critical and non-critical areas and can design a program based on the customer needs.
Viable Air Monitoring by Biotest Units – Microbial Air Sampler collects a predetermined volume of air and impact microorganisms against a sterile agar-based growth medium. Once that sample has been collected and the medium incubated, the results are expressed in colony forming units (CFU) per cubic meter. The isolated organism can then be identified to genus and species.
Viable Surface by RODAC, Contact strip or swab – Personnel and surface monitoring is a critical tool in all industries where measures are taken to keep production plants clean and minimize the risk of contamination. To monitor the efficiency of these measures, proven methods are required, such as easy-to-use contact plates (RODACS), contact slides or swabs. Choice of media in the contact plate depends on the environment and the perceived microbiological risks.
Companies who monitor their clean rooms for Environmental purposes do so to meet regulatory requirements. Data generated by microbiological testing can be monitored for trends with alert and action levels set.