503A/B Facilities

Cleanroom Consultants

Is your compounding facility registered or looking to become a registered 503A or 503B facility? Where do you begin? What is required? Is the registration with the FDA necessary? How do you maintain the process? If these are questions you are facing, choose Cleanetics to walk you through the process and ensure that you are on the right path to FDA approval. Cleanroom Consultants and knowing the advantages to both facilities is our specialty.

The questions you may have:

1. Are we preparing sterile compounded drugs/hazardous/non-sterile?

2. Do we wish to register as an outsourcing facility?

3. We are not a registered pharmacy but do have a pharmacist that will supervise all compounding?

4. Will our facility obtain or not obtain prescriptions for identified individual patients?

Cleanetics can assist you with your questions, design, construction, certification and maintenance of your facility.  

 

Cleanetics' Cleanroom Project Gallery

ISO 5 Cleanroom
Pharmacy Facility
503B Facility
503B Facility
503B Facility
Decontamination Air Shower
Cleanroom Renovation
USP<797> Cleanroom
E Hall Wall Looking N
USP<797> and <800> Cleanroom
Custom Material Pass-Through
Brook Haven National Laboratory
Cleveland Clinic Custom Granite
USP 797 Cleanroom
USP 800 Preparation
USP 797 Sterile Compounding
Custom Casework

Design/Build Location:

110 5th Street

West Elizabeth, PA 15088

412-405-8374

Corporate Office:

6850 N. Haggerty Road

Canton, MI 48187

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