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503 A/B

503A/503B Cleanroom Consulting, Construction, & Maintenance

503A/B Cleanroom under construction

Is Your Compounding Facility Registered or Looking to Become a 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.

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503 A Cleanroom
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503 A Cleanroom
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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.
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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)

Frequently Asked Questions

 

What is the difference between 503A and 503B compounding pharmacies?

The main differences between 503A and 503B compounding pharmacies are the batch sizes they can produce and their regulatory standards. A 503A facility compounds prescriptions specific to patients, is limited to dispensing only for home use, and is not permitted to compound large batches.

A 503B compounding pharmacy is also allowed to compound patient-specific prescriptions, but they are permitted to compound large batches of prescriptions to be sold to healthcare facilities for office-only use (physician offices, clinics and hospitals). The FDA holds 503B facilities to higher manufacturing standards and requires they must be fully compliant with cGMP (current good manufacturing practice) regulations.

What are the requirements of a 503B facility?

A 503B compounding pharmacy must comply with cGMP (current good manufacturing practice) regulations, all of its compounded drugs must be compounded under the supervision of a licensed pharmacist, and all of its compounded medications must be inspected by the FDA.

Because of the strict regulations put on 503B compounding facilities, they must also report on all of the products compounded in the pharmacy including a list of all of the medications compounded in the past six months, the source of their ingredients, and adverse events that may occur within the facility.

What are common 503B compounding cleanroom specifications?

The specifications for a 503B compounding cleanroom can differ depending on your process requirements, but the FDA states that all sterile drugs be produced in an ISO Class 5 (Class 100) zone or higher. ISO 7 (Class 10,000) and ISO 8 standards are also commonly required for these facilities.

 

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

 

Schedule a Consultation Now

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Get Started with Cleanetics Today!

Call Us:
(412) 405-8692
Hours of Operation:
Mon-Fri: 7:30 AM - 4:30 PM
Sat-Sun: CLOSED
Design and Build Office:
110 5th Street
West Elizabeth, PA 15088
Headquarters:
6850 N. Haggerty Road
Canton, MI 48187
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