Monitronics - USP 797 Compliance

Advanced Contamination Control Technologies

USP <797> Compliance

USP <797> has now been published and is available. The requirement set forth within this document becomes effective June 1st, 2008.

While some facilities do present some daunting challenges were engineering controls are concerned, when properly managed and researched, gaining compliance to these new requirements need not be exceedingly costly or problematic. The ultimate goal of our <797> services is to work with each customer towards this end.

Facility Modification or New Construction

Our approach towards compliance is simple and direct. Each project is begun by conducting an onsite assessment of the pharmacy via meetings with key personnel to determine the types and volumes of compounded product expected to be produced at the facility. Considerations documented at this initial design stage include the future goals of the organization as well as the size, location, and limitations of existing utilities present within the area to be built or upgraded. Placing key pharmacy personnel into the design review process from the first day assures good communication and prevents the end user from being "out of the loop" on their own project. Our project quotes are researched and detailed to eliminate change orders. Change orders routinely increase project cost by 10-20%, and are usually due to unit pricing or a lack of detail during initial reviews.

Validation, Certification and Routine <797> Monitoring

With over thirty years experience in the conduct of culturable industrial microbiological environmental testing and an in-house laboratory both timely and cost effective routine monitoring is assured. Samples are placed into incubation the same day they are collected and shipping expense eliminated. Care is given to ensure that results are useful in managing the contamination control program of the customer, not just becoming a piece of paper filled away because of a standards requirement. When out of specifications results are recovered, a review of historical data is utilized to provide guidance on corrective actions needed to document a return to normal operational conditions.

Procedural Documentation, Training and Consultation

While working towards compliance required by new industry requirements, it is always important to design standard operating procedures which provide the required level of control while being practical to the end user and realistic given the variables present in the operation. We believe that our interdisciplinary experience in the fields of industrial microbiology, contamination control technologies, clean room design and construction, quality assurance and regulatory affairs sets our program above any currently offered. Please feel free to contact us so we can discuss your needs, no matter how small or large.

Overview of USP <797> Project Development

Meet with Pharmacy Management to assess type of operations performed, Risk levels present, volume of preparations, and work flow considerations.
Determine best locations for compounding and/or chemo areas and review associated mechanical plans, air balance reports, and local supply/exhaust/return air volumes.
Establish scope of project, determine team members required to complete the project and prepare quote.
Review quote with Pharmacy management and facilities management.
Execute provisions for site contamination control measures during construction.
Build, clean and validate revised environment.
Provide documentation as to mechanical and microbiological compliance of finished chemo/compounding area per USP <797>.

Operational Overview of USP <797> Requirements

Hazardous Drugs:

Ante room meets ISO Class 7.
ISO Class 5 BSC or CAI is located in an ISO Class 7 room that is physically separate and no less than 0.01 inch water column negative pressure to adjacent ISO 7 ante room.
BSC or CAI shall be 100% vented to the outside air through HEPA filtration.
Ventilation rates shall provide 12 ACPH in the area.
If a CAI meeting all the requirements of the standard is employed HEPA filtration of ventilation air may be eliminated.
Very low volume facilities may in some situations eliminate HEPA filtered ventilation air.

Compounding Areas:

Clean room HEPA filtered air to total 30 ACPH, 15 ACPH through room supply, and 15 ACPH through recirculating ISO Class 5 Air associated with a LAF hood. (Minimum requirements).
Ante room meets ISO Class 8 requirements
Clean room meets ISO Class 7 requirements
Low level returns are employed with construction surfaces easily disinfected, sealed, and meeting the requirements of the standard.
Minimum positive air pressure differential of 0.02-0.05 inches water column.
If clean rooms and ante rooms which are not physically separated the displacement concept may be utilized provided high risk compounding is not performed in the area.