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Environmental Monitoring in Irvine, CA

 

Having a clean workspace is important in any industry, but it’s an absolute necessity if you work in the pharmaceutical or medical industries. For these industries, a clean workspace means more than just having a fresh, clutter-free building. Working in these fields requires a sterilized clean room where the concentration of airborne particles is controlled to minute limits to avoid disruption or product contamination. When you need a clean, safe work environment, turn to our professionals for environmental monitoring in Irvine, CA. With our help, you can be confident not only in the health and wellness of your employees, but also in your compliance with various manufacturing regulations.

Within the pharmaceutical industry, it’s imperative that clean rooms meet rigorous cleanliness standards. The real objective of a clean room is to ensure its sterility. While some products may not be sterilized until the end of production, other processes require fully aseptic manufacturing operations. In this case, it’s crucial that your end product is not contaminated by even the smallest amount of microbial or particulate matter.

At our clean room manufacturing company, our GMP manufacturing technicians are committed to keeping our clients’ spaces safe, controlled, and biologically clean. We work to ensure your work environment meets regulations and minimizes any risks during productions from testing through the distribution of the final product.

 

Benefits of Working with Our GMP Manufacturing Technicians

A GMP or good manufacturing practice is a system put in place that helps ensure that products are produced and controlled according to industry standards. GMPs cover every aspect of production from the raw materials, premises, and equipment to the training and the personal hygiene of staff members. Having detailed written procedures are essential for each process that inherently affects the quality of the end product. When you turn to our GMP manufacturing technicians, we take a meticulous approach to keeping your environment cleaned to code. This way, we ensure that the correct procedures are consistently followed at each step of your manufacturing processes.

 

The Importance of Good Manufacturing Practices

When it comes to environmental monitoring, most industries concerned with viable microorganisms have published standards or use current Good Manufacturing Practices (cGMP) to ensure manufacturing facilities is routinely cleaned according to industry standards. These industry practices are continuously evaluated by our GMP manufacturing technicians, confirmed or negated through OQ and IQ.

The viable action and alert levels are determined and set via the original design and work in progress using company developed standard operating procedures (SOP) for which validation is performed for the product manufacturing process. This validating system allows your company to determine its own risk assessment of the manufacturing process. When it comes to environmental monitoring, this risk assessment is based on a number of factors. The factors include the product being manufactured, the design of the cleanrooms, the products used, and the amount of people working in the rooms.

All cleanroom designs, environmental monitoring conditions, as well as manufacturing and personnel conditions differ across various industries and within the same industry as well. For example, a pharmaceutical company making a vaccine may have different SOPs or validation results than a competitor making the same product, yet they may both be successful. Most product non-conformities or high microbial levels in the environment have resulted from GMP manufacturing technicians not following protocol, facility compromises or improper cleaning and disinfecting. Epidemics of disease of contamination of pharmaceuticals are much less likely to occur when the following SOPs are followed:

• Room Surface Testing

• Air Sampling

• Detail Report

• Incubate and Count

• Testing Design Plan

• Isolates Identified to Gross Morphology and Gram Staining

• Species Identification

• Continuous and Periodic Validation (IQ, OQ, and PQ)

As a dedicated environmental monitoring company, we understand the importance of taking a meticulous approach to the cleanliness of your work environment. From the quality of your indoor air, to its particulate matter, we believe that no elements of your space are too small to ignore. When your job requires a workspace cleaned to the nth degree, entrust our GMP manufacturing technicians to keep facility cleaned to code.


 

• Room Surface Testing
• Air Sampling
• Detail Report

• Incubate and Count
• Testing Design Plan
•  Isolates Identified to Gross Morphology and Gram  Staining

• Species Identification
• Continuous and Periodic Validation (IQ, OQ, and PQ)

 


 
 

Service Area: Nationwide