Filtration Technology, Inc.- Filtration and Contamination Control Specialists
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Cleanroom Compliance

Under the revised USP Chapter 797 regulation, all compounding pharmacies are required to protect their products by utilizing a laminar flow workbench within a cleanroom. Greater care and cleaner facilities are now required for Compounded Sterile Preparations (CSPs).

Background

Since 1971, Filtration Technology Inc. has planned, designed and constructed medical and industrial cleanrooms. Filtration Technology Inc. stands as one of the most experienced sources for Cleanroom Design/Build Construction in the industry. For the past 12 years our principal, Richard A. Matthews, has been the World Chairman for the International Standards Organization (ISO) Technical Committee for Cleanrooms and Associated Controlled Environments.

USP 797 refers to these ISO Global Cleanroom Standards; specifically the ISO 14644 series of standards.

The current air cleanliness requirement for a Compounding Cleanroom is an ISO Class 8. A separate ISO Class 5 Device is required for the compounding of patient preparations. All sterile compounding is to be performed in an ISO Class 5 Device surrounded by an ISO Class 7 or ISO Class 8 Cleanroom Buffer Zone. "Risk Level " determines the required ISO cleanroom air cleanliness classification.

Determining your Risk Level

In order to set your ISO Cleanroom Classification you must first determine your Risk level.

Low-Risk Level Compounding

  • Low-risk level compounding occurs in an ISO Class 5 environment and involves only a few basic, closed-system steps.
  • Specific examples include the following:
    • Using sterile syringes with sterile needles to conduct single sterile dose transfers from the manufacturer's original packaging such as; ampoules, bottles, bags and vials
    • Mixing and measuring up to three (3) sterile products to compound drug admixtures
    • Prep hydration solutions
    • Compounding Sterile Products (CSPs) from sterile commercial drugs using commercial sterile devices
  • Recommended ISO Air Classifications
    • CSPs to be prepared in an ISO Class 5 Laminar Air Flow Workbench (LAFW)
    • LAFW to be inside of an ISO Class 7 or ISO Class 8 Cleanroom
    • Ante-Room leading into Cleanroom to be an ISO Class 8 Cleanroom

Medium-Risk Level Compounding

  • Medium-risk level compounding involves complex aseptic manipulations/procedures other than single volume transfer, and it may occur over a prolonged period of time. In addition, it incorporates pooled sterile products for multiple individuals, or small doses or for one patient multiple times.
  • Specific examples include the following:
    • Total Parenteral Nutrition (TPN) solutions using automated or manual compounders
    • Chemotherapy or pain management administered by an infusion device
    • Pooled admixtures
    • Batched antibiotics
    • Transfer of multiple ampoules or vials into a single final sterile container or product
    • Batch-compounded preparations that do not contain bacteriostatic components
  • Recommended ISO Air Classifications
    • CSPs to be prepared in an ISO Class 5 Laminar Air Flow Workbench (LAFW)
    • LAFW to be inside of an ISO Class 7 Cleanroom
    • Ante-Room leading into Cleanroom to be an ISO Class 7 Cleanroom

High-Risk Level

  • High-risk level CSPs take place when non-sterile ingredients are incorporated or a non-sterile device is utilized before terminal sterilization. Also, for sterile ingredients, components, devices that are exposed air quality substandard to ISO Class 5. Non-sterile products are exposed to air quality inferior to ISO Class 5 for more than six hours passes between compounding and sterilization. Storage periods cannot exceed; 24 hours at controlled room conditions, 3 days at cold temperature and 45 days for solid frozen state at -20 C or colder.
  • Specific examples include the following:
    • Dissolving non-sterile bulk drug and nutrient powders for solution preparation that will be terminally sterilized
    • Open storage in an environment inferior to ISO Class 5 for sterile ingredients, components, devices and mixtures
    • Using final containers that are non-sterile and must be terminally sterilized
  • Recommended ISO Air Classifications
    • CSPs to be prepared in an ISO Class 5 Laminar Air Flow Workbench (LAFW)
    • LAFW to be inside of an ISO Class 5 Cleanroom
    • Ante-Room leading into Cleanroom to be an ISO Class 7 Cleanroom

Allow us to become a team member to assist you in determining your requirements. We can provide you with a no cost audit that consists of a site survey, particle counts and a written report.

Our comprehensive turnkey service, and the proper management of your cleanroom project from design through completion can bring the advantages of cleanroom technology to your facility. We can support your needs after construction with complete system maintenance. Our team of professionals will work with you to determine your application's specific cleanroom needs, considering both your immediate and long-term goals.

Our experience with sterile compounding facilities in hospital pharmacies, home infusion pharmacies and retail pharmacies will help you determine your requirements.

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If you would like some help with this form or prefer to discuss your cleanroom needs over the telephone, call 1-800-338-4280
Width Length Height
Cleanroom Dimensions
Gown/Ante room dimensions
 
Do you consider your Compounding to be:
Low Risk
Medium Risk
High Risk
Or  
Have you determined your Cleanroom Classification:
ISO 5
Yes No
ISO 7
Yes No
ISO 8
Yes No
   

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Will you need separate air conditioning for this cleanroom?
  Yes Not necessary, existing AC is sufficient
   

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How many electrical receptacles? (enter a number or "not sure")
Any 208 volt receptacles: (enter a number or "not sure")
   
Other needs for your cleanroom? (Laminar flow hoods, furniture, etc.)
   

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Name:
Phone:
E-mail:
Fax:
   
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Filtration Technology, Inc.
P.O. Box 18168 -- Greensboro, NC 27419
Tel (336) 294-5655 -- Fax (336) 854-0454  .  E-Mail: sales@filtrationtechnology.com
Customer Service Telephone: 800-338-4280

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