Microbial Environmental Monitoring

Medical device manufacturers use microbial environmental monitoring programs to evaluate the effectiveness of cleaning and disinfection procedures and to assess the overall microbial cleanliness of their manufacturing environment. An effective program to control microorganism levels in the manufacturing environment is essential to minimize the bioburden on the medical device being manufactured and reduce potential for bioburden spikes. Spikes in the bioburden of finished medical devices can cause a reduction in the sterility assurance level for the product.

SGS works with many of its clients to establish and maintain cost-effective programs to meet FDA requirements for monitoring the microbial cleanliness of their manufacturing environments and assessing the efficacy of production area disinfection procedures. Our microbiologists can travel to your facility to perform a microbiological survey.

Air and surface samples are taken during routine production operations to obtain a microbiological profile of the manufacturing environment. Observation of work practices are made during the survey. Test data and other information are evaluated to determine what actions can be taken to reduce or stabilize the bioburden of the medical device. Once an intensive survey has been conducted and strategic sampling locations are determined, our microbiologist can train the manufacturer's personnel to collect microbial samples on a regular schedule. SGS can provide the necessary supplies for microbiological sampling. Exposed materials are returned to SGS for enumeration and report. Please contact us to order supplies or for more information.

Environmental Survey – Microbiological
(Performed by SGS Personnel)

Microbial Environmental Monitoring Supplies *

• Fallout Plate, 100 mm, Tryptic Soy Agar (TSA)
• Fallout Plate, 100 mm, Sabouraud Dextrose Agar (SDA)
• Contact Plate, DE Neutralizing Agar
• Contact Plate, Tryptic Soy Agar
• Contact Plate, Sabouraud Dextrose Agar
• Biotest Air Sampler Strip, TSA
• Biotest Air Sampler Strip, SDA or Rose Bengal Agar
• Biotest Centrifugal Air Sampler – Daily Rental
• Sterile Buffer Solution w/Dacron Swab
• Sterile Specimen Cups, Screw Cap, 120 mL
• Surgeon’s Gloves, Latex, Sterile (available in sizes 6 to 8 ½)
• Antiseptic Gel Hand Rinse, 4 oz. bottle

* Microbial monitoring supplies are usually shipped in coolers. There is a packaging charge per supply order. Shipping charges are billed at cost.

Microbial Samples – Incubation, Enumeration and Report

• Fallout Plate Count
• Contact Plate Count
• Biotest Air Sampler Strip Count
• Buffer Solution – Aerobic Count (Membrane Filtration)