Article provided by: Pacific Environmental Technologies, Inc.
Compounding pharmacies requires the cleanest facilities. Pacific Environmental Technologies, Inc., a California licensed construction firm formed in 1989, creates high-value clean rooms, dry rooms, and cold storage to meet the needs of the industry.
Starting a sterile compounding pharmacy
Drug compounding is the process of combining the effects of multiple drugs in a single package. This process creates specially tailored medication, often on a per-patient basis.
It is important to note that these drugs are not FDA-approved for mass consumption. One person’s physiology is not always the same as another patient’s and you must account for these variations.
Why do contaminants damage compounding pharmaceuticals?
Drug compounding is a hazardous process. Humidity can carry bacteria and dust that mixes with drugs in a way that can harm patients.
The smallest amount of dust entering the bloodstream may have dire effects. The impact of a single death reverberates through your business in undesirable ways.
What regulations govern the creation of compounded drugs?
Since drug compounding is a risky process, the federal government established regulations to avoid health risks. USP 797, in place since January 2004 is a set of guidelines for creating controlled facilities that eliminate most major sources of contamination.
USP 797 cleanrooms for sterile compounding pharmacies rely on ISO standards to live up to the strictest regulations. Ventilation, pressure systems, controls, ante rooms, and even the water column in the adjacent area must live up to some of the highest standards in any industry.
Do cleanrooms meet government standards?
Compounding pharmacies clean rooms from Pacific Environmental Technologies, Inc. live up to the guidelines. With decades of licensed experience, we understand how to avoid risk.
Our conventional and modular cleanrooms use state-of-the-art panels, filtration systems, and installation practices to keep your company in business. We help meet fire ratings while maintaining the flexibility and scalability offered by our modular wall panels.
Flexible and scalable cleanrooms
Businesses grow and cleanrooms are expensive. Continuing to build out new space to USP 797 is often unsustainable.
Among our cleanroom products for compounding pharmacies is a modular room. Our own tightly locking wall panels and ISO compliant containers give your workforce the power sterility without building directly for your space.
How do I maintain my cleanroom?
The finish you have will govern how you keep your cleanroom clean. Sterile compounding cleanroom supplies are almost always temperature sensitive.
To accommodate temperature sensitivity, we also provide modular cold storage. Highly insulated, temperature-regulated rooms maintain the effectiveness of your products throughout their specified lifetime and keep you in business.
Who constructs clean rooms in California?
Pacific Environmental Technologies, Inc. offers the flexibility and value you need to succeed at a cost you can afford. Rather than cut corners in construction, we devised a highly modular system allowing you to scale with ease.
Decades of experience seeing the rise of guidelines regarding compounding pharmaceuticals gives us an edge in creating highly sterile rooms to keep your business humming. Get in touch with our team today to see how we can help you grow.Compounding Pharmacies