Barrier Isolator Compliance

Under the revised USP Chapter 797 regulation, all compounding pharmacies are required to protect their products by utilizing a barrier isolator or 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. stands as one of the most experienced sources for Serparative Devices such as Barrier Isolators and other Laminar Air Flow Equipment. Our principal, Richard A. Matthews, has been the World Chairman for the International Standards Organization (ISO) Technical Committee for Global Cleanroom Standards and Associated Controlled Environments for the past 12 years.

USP 797 refers to these ISO Global Cleanroom Standards; specifically the ISO 14644 series of standards. The ISO Standard for Barrier Isolators is addressed in ISO 14644-7.

A Choice between a Cleanroom and a Barrier Isolator must be determined based upon your process. Controlled clean environments commonly referred to as Cleanrooms can be expensive spaces. A self-contained, controlled, clean environment enclosure, A Barrier Isolator, around a critical care process area can be an economical alternative to a Cleanroom. To read an article titled “Controlled Clean Environment Enclosures by Richard Matthews, click here.

Simplicity and efficiency are necessary features of a specialized Separative Device that requires professional attention to your functional process.

A well-designed positive pressure Barrier Isolator supported by adequate procedures for maintenance, monitoring and control may be an acceptable alternative to Laminar Air Flow Devices and a Cleanroom.

Determining your Risk Level

In order to determine whether or not you will choose a Barrier isolator or an ISO Cleanroom 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

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

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

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 commitment to high quality standards has created reliable specialty filtration and contamination control systems that bring the advantages of our technology to your facility. Our team of professionals will work with you to determine your application's specific 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.