USP <800>, is the document published by The United States Pharmacopeia (USP) which describes practice and quality standards for handling Hazardous Drugs (HDs), including the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations. While it is a large document that thoroughly covers all aspects of HD drug compounding, the purpose of this blog entry is to outline some of the sections and specific wording in USP 800 that we (Travis CleanAir) take into account when designing a Non-Sterile Hazardous room.
One of the more common rooms we’ve been requested to build by our clients in recent years is the Non-Sterile Hazardous Room (NSH Room); essentially a negative pressure secondary enclosure to contain hazardous materials as well as your hoods and other various equipment being used for non-sterile hazardous compounding. Reading through USP 800, you will see two important terms applying to this:
One of the more common rooms we’ve been requested to build by our clients in recent years is the Non-Sterile Hazardous Room (NSH Room); essentially a negative pressure secondary enclosure to contain hazardous materials as well as your hoods and other various equipment being used for non-sterile hazardous compounding. Reading through USP 800, you will see two important terms applying to this:
- C-PEC (Containment-Primary Engineering Control): a ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs.
- The CPEC is typically your BSC (Biological Safety Cabinet), CVE (Containment Ventilated Enclosure, also called a powder hood), or a CACI (Compounding Aseptic Containment Isolator, also called a Glove Box). Broken down into its simplest form, it’s the hood you do your actual compounding in.
- C-SEC (Containment-Secondary Engineering Control): The room in which the C-PEC is placed. Applying to TCA, this is the isolated NSH room we design/build for our clients to house their NSH/Sterile HD/Sterile compounding and testing operations.
When compounding non-sterile HD’s, compounding must take place within a C-PEC located inside a C-SEC. Or in other words, a hood inside a room. The C-SEC itself must meet certain requirements for compounding HD’s, whether Non-Sterile or Sterile. These C-SEC room requirements are:
- Must be externally vented
- Must be physically separated
- Must have an appropriate ACPH (Air Change Per Hour – Non-Sterile Hazardous room standard is 12 ACPH)
- Must have a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas
- Due to the difficulty of cleaning HD contamination, surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the nonsterile compounding area must be smooth, impervious, free from cracks and crevices, and non-shedding.
Your C-PEC, (Hood) used for Non-Sterile HD compounding has its own set of rules as well:
- Must be either externally vented (preferred) or have redundant-HEPA filters in series
- Must provide personnel and environmental protection such as an appropriate BSC (Class I or Class 2), CVE, or CACI
- Side Note: A Class II BSC or CACI that is being used for sterile compounding in a sterile cleanroom may be used for occasional Non-Sterile HD Compounding, but it must be decontaminated, cleaned, and disinfected before resuming sterile compounding in that C-PEC
- C-PEC must be located at least 1 meter away from any water sources or drains. While UPS 800 lists this as a requirement only for sterile rooms, TCA follows this guidance on our NSH designs as an added precaution.
With those guidelines in mind, we can start to shape our NSH room design based on the client provided specifications. Additional information we require from our clients is covered in our initial Project Questionnaire, such information includes dimensions of usable space, types of compounding planned to be done in the workspace, number of hoods and hood types.
USP 800 Appendix 2 shows a whole page of simple example drawings of Sterile and Non-sterile rooms that leave much to the imagination.
USP 800 Appendix 2 shows a whole page of simple example drawings of Sterile and Non-sterile rooms that leave much to the imagination.
Example: USP 800’s sample NSH room
At Travis Clean Air, all of our rooms are modeled in 3D from the initial drawing. This eliminates any misconceptions as to the scale or aesthetics of our cleanrooms, and allows us to have a full list of needed materials to build your cleanroom from the initial draw.
Example: One of our standard NSH designs shifting from top down 2D view used for design documents, to 3D front view
In order to keep our C-SEC negative per USP 800, our standard Non- sterile hazardous room includes an exhaust plenum in case the C-PEC loses power and fails to keep the room under negative pressure. As with everything else in our rooms, the size and location of the plenum is entirely customizable based on our client’s needs.
Example:
Example: One of our standard NSH designs shifting from top down 2D view used for design documents, to 3D front view
In order to keep our C-SEC negative per USP 800, our standard Non- sterile hazardous room includes an exhaust plenum in case the C-PEC loses power and fails to keep the room under negative pressure. As with everything else in our rooms, the size and location of the plenum is entirely customizable based on our client’s needs.
Example:
- Outside Air is pulled into the C-SEC through an external low wall vent
- Air is pulled into the exhaust plenum via internal low wall vent
- Air moves up the plenum chamber and is externally exhausted
All Travis Clean Air rooms are designed with our client’s airflow needs in mind from our initial drawings to our final design documents. Whether it’s a USP 800 or USP 797 room, we guarantee you’ll pass certification. If you still have questions regarding an 800 compliant or any other cleanroom, we can work with you one on one to determine your requirements, and have a sample design based on your needs in a matter days.
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