Incentives for implementing environmental monitoring systems include (but are not limited to):
- Identifying the microbial flora within a designated environment in order to accurately develop the sterilization parameter(s).
- Determing seasonal trends to ensure control of the products Bioburden and Sterility Assurance Level (SAL) dose.
- Determining environmental cause and effect relationships.
Dynatec maintains equipment and associated international work permits in order to meet the needs of its medical device customers who operate maquiladoras in Mexico. Dynatec’s staff is experienced in Current Good Manufacturing Practices and Quality System Regulation (QSR) and can assist manufacturers in meeting these guidelines.
In addition, Dynatec’s staff can conduct training of in-house personnel in English or Spanish in order to meet the current standards.
Dynatec’s Monitoring Methods:
- Particulate Air Monitoring – A quick parameter used to enumerate the number of non-viable particulates in a given volume of air. This is also used to determine the efficacy of air filtration systems in manufacturing environments. In addition, particulate air monitoring is used to certify clean rooms in accordance with ISO standards. Air monitoring is conducted with a laser particle counter which has a detection range of 0.3 to 10 microns.
- Viable Air Monitoring – Air sampling conducted to determine the number of viable airborne microorganisms in a measured volume of air. This monitoring system can assist in isolating contamination sources, evaluating seasonal trends in air filtration systems and ultimately leads to quality control systems, minimizing variation in manufacturing environmental contamination levels.
- Surface Sampling – Used as an adjunct to viable air monitoring. The swab method and rodac contact plate methods are routinely used.
- Water Analysis – Investigative tool used to evaluate the biological and or toxicological characteristics of water used in the manufacturing process.
- Compressed Air -Dynatec Labs is a third party laboratory for the certifitification of manufacturers of compressors in accordance with ISO standard 8573.
Dynatec’s staff is available to assist you with your Environmental Monitoring needs. Call 915-849-1322 (ext. 107) or email us.
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