USP 797 Compliance
What is USP 797? Does it apply to my pharmacy?
USP 797, the “Pharmaceutical Compounding – Sterile Preparations” chapter, outlines that sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles.
If your pharmacy currently performs sterile compounding (or will be in the future), the new USP 797 chapter applies to you.
Common sterile compounding applications involve:
- injections
- ophthalmic solutions
- ointments
- IV admixtures
- inhalation solutions
- allergens
- bladder irrigating solutions
There are many aspects of compliance with regard to this revised chapter. To download a free copy of the updated USP 797 chapter for your own guidance and interpretation, please follow this link: http://www.usp.org/pdf/EN/USPNF/generalchapter797.pdf
AirClean® Systems can help your pharmacy comply with USP 797.
AC632LF Vertical Laminar Flow Workstation
According to USP 797, sterile compounding is to be prepared in an ISO 5 environment. AirClean® Systems manufactures ISO 5 vertical laminar flow workstations and horizontal laminar flow benches. Our workstations provide unidirectional airflow on the direct compounding area (DCA), which allows for optimum 'first air' contact with your application. Available in several sizes, AirClean® Systems laminar flow workstations are ideal for pharmacies looking for a USP 797 compliant containment solution for sterile compounding.
While both horizontal and vertical laminar flow workstations provide process protection in an ISO 5 environment, there are some differences between them. Which one is right for your pharmacy? It depends on your needs and the space you have available. Both styles are designed to fit on a standard bench top and plug into a regular 110V AC outlet. AirClean® Systems Horizontal Clean Benches are available in 52’’, 60’’, 72’’, and 102’’ widths. The Vertical Laminar Flow Workstations are available in 24’’, 32’’, and 48’’ widths.
Click to jump to dimension chart for Vertical and Horizontal Laminar Flow Hoods.
Is a compliant workstation all that is required?
There are many elements of compliance to the revised USP 797 - with primary engineering controls (hoods & workstations) constituting a single sub-section. According to the revised USP 797 chapter, primary engineering controls should be located in an ISO 7 (Class 10,000) clean room known as the buffer area. AirClean® Systems will work with your pharmacy to determine the appropriate sized workstation for your clean room.
Also, the type of sterile compounding performed in your pharmacy may dictate the type of workstation that best aides in your compliance. AirClean® Systems unidirectional workstations are available with optional features to assist the pharmacist in dose preparation. For example, our horizontal clean benches are offered with an optional IV bar.
ISO 5 Laminar Flow Workstations:
Click either of the following images to learn more about the workstation type:
Vertical Laminar Flow Workstation Features:
- Provides ISO 5 clean environment
- UVTect™ microprocessor controller
- Seamless, clear polycarbonate shell
- Monitored vertical laminar airflow
- Available in 24", 32" and 48" widths
Horizontal Clean Bench Features:
- Provides ISO 5 clean environment
- UVTect™ microprocessor controller
- All polypropylene, seamless construction
- Monitored horizontal laminar airflow
- Available in 52", 60", 72" and 102" widths
Please click the Quote Request button above or call AirClean Systems at 1-800-849-0472 for more information and pricing on these workstations.
Available Sizes
| AC600 Series Vertical Laminar Flow Workstations | |||||
| AC624LF | AC632LF | AC632TLF | AC648LF | AC648TLF | |
| EXTERNAL DIMENSIONS | |||||
| Width | 24" | 32" | 32" | 48" | 48" |
| Depth | 24" | 24" | 24" | 24" | 24" |
| Height | 30" | 30" | 40" | 32" | 42" |
| INTERNAL DIMENSIONS | |||||
| Width | 23" | 31" | 31" | 47" | 47" |
| Depth | 23" | 23" | 23" | 23" | 23" |
| Height | 19" | 18" | 28" | 20" | 30" |
| Horizontal Laminar Flow Bench Dimensions | ||||
| AC4000HLF | AC5000HLF | AC6000HLF | AC8000HLF | |
| EXTERNAL DIMENSIONS | ||||
| Width | 52" | 60" | 72" | 102" |
| Depth | 30" | 30" | 30" | 30" |
| Height | 40" | 40" | 40" | 40" |
| INTERNAL DIMENSIONS | ||||
| Width | 47" | 59" | 70" | 97" |
| Depth | 22" | 22" | 22" | 22" |
| Height | 27" | 27" | 27" | 27" |
