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503 A/B

Our Team Can Consult, Design, Build, and Certify Your 503 A/B Facility


Registered 503A or 503B Cleanroom Facilities | Cleanetics - c6

Is Your Compounding Facility Registered or Looking to Become an Registered 503A or 503B Cleanroom?

Where do you begin? What is required? Is 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 ensure FDA approval.

Cleanetics has been designing and building 503A/B cleanroom facilities that meet the FDA requirements from design to certification. Working closely with our clients we can develop a cleanroom that meets your sterile compounding regulations and can provide your facility the opportunity for expanded growth. Our staff is highly trained in the 503A/B process and stays up to date on all USP Federal Regulations to keep you in compliance.

One of our past projects consisted of a turnkey design/build cleanroom construction for a 900 sq/ft hazardous compounding pharmaceutical production line facility.

Details of One of Our Previous 503 A/B Projects Include:

  • Building in an open warehouse
  • Custom 30 ton Trane RTU with CRC controls
  • Segregated negative and positive ISO7 anteroom/buffer room
  • ISO 5 critical negative pressure compounding cleanroom
  • Bio-Gard Wall Laminate System
  • Homogenous, non-porous and durable surfaces
  • Capabilities to expand in the future without interruption to the existing compounding.
Registered 503A or 503B Cleanroom Facilities | Cleanetics - cleanroom4

When You Have Questions, We Have Answers

When we begin the process of designing and building a cleanroom for our 503 A/B clients, they often have questions about their own processes and look to us to put their mind at ease. We are able to resolve their concerns by explaining how our innovative cleanrooms can take care of each of their specific needs. Feel confident hiring Cleanetics to handle all of your compounding pharmacy cleanroom requirements.

Contact Us with Your 503 A/B Cleanroom Questions

Common Questions We Often Address

  • How do we prepare to expand our compounding production and outsourcing capabilities?
  • What do we need to become 503B registered?
  • Are we preparing sterile compounded drugs/hazardous/non-sterile?
  • Should we register as an outsourcing facility?
  • We are not a registered pharmacy but should we have a pharmacist to supervise all compounding?
  • Will our facility obtain or not obtain prescriptions for identified individual patients?

We Service Our Clients With:

  • Monthly, quarterly, or semi-annual packages
  • Certification to ISO Standard 14644-1
  • BSC/LAFW equipment certification
  • Aerosol filter scan
  • Inspection of all equipment for proper operation
  • HVAC inspection and cleaning; Clean/replace FFU/HEPA pre-filters; Clean/replace FFU/HEPA pre-filters
  • Inspection of return air risers and wall cleaning
  • Pressure, Temperature, and Humidity Monitoring
  • A review of cleaning procedures for compliance
  • Microbial Viable Testing (Air and Surface)

Consult with Cleanetics to build and/or renovate your 503A or 503B facility that is guaranteed to pass State, DOH, and Federal Standards.

 

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