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Pharmacies
United States Pharmacopeia 
Chapter 797 (USP 797)
Design Build Program

This program provides the physical and environmental design criteria for compounded sterile preparation (CSP) controlled environments for pharmacies based on the requirements of United States Pharmacopeia (USP) Chapter 797. Precision Constructors personnel and associates have extensive experience in constructing new and renovating existing pharmacies to meet stringent USP 797 construction requirements.

GENERAL

Precision Constructors personnel have exhaustively researched the construction requirements of United States Pharmacopeia Chapter 797 which takes into consideration all interior surfaces, windows, doors, and light fixtures, along with air changes, pressures, filtration, and particulate, temperature & humidity controls.

The compounded sterile preparation clean rooms and anterooms are designed to meet the facility requirements specified by the client, as well as all applicable laws and regulations and other current standards of practice. We work closely with the facility Owner and Engineering Department to create a controlled environment which will enhance the pharmacy’s ability to attain the highest level of quality assurance.

The Pharmacy compounding areas will include (at a minimum) an ISO Class 8 Anteroom also known as Ante/Gowning Room and an ISO Class 7 Clean Room also known as a Barrier Room;  with ISO Class 5 workstations in the form of some combination of the following: Biological Safety Cabinets, Barrier Isolators, Laminar Airflow Hood or Laminar Airflow workbenches.

 

PROGRAM:

                                         

1          Pharmacy Survey  

1.1     Evaluate the design requirements pertaining to the state’s laws and regulations relative to USP Chapter 797. 

1.2     Perform a physical inspection to determine all existing conditions including layout & dimensions, and mechanical, plumbing, electrical & lighting systems. 

1.3     Conduct an operational survey to determine the sterile compounding methods and requirements. Includes evaluations for low, medium & high risk Compounded Sterile Preparations (CSPs) needs as well as hazardous drugs & radiopharmaceutical CSP needs. 

 

2          Design & Estimating

2.1     Take survey results to the Architectural and Engineering (A/E) design review phase. Establish the baseline design criteria and order schematics. Provide a detailed rough estimate of the anticipated total cost of the project to the Owner for approval. 

2.2     Perform 50%, 80% and 95% complete design reviews and work with the A/E team to complete a pharmacy design that is ready for Owner Review. 

2.3     Perform design review with the Owner to establish a set of final review comments for the A/E team. 

2.4     Coordinate the completion of the final set of permit ready construction documents. 

 

3          Permitting

3.1      Establish all permitting requirements with local and state authorities having jurisdiction (AHJ). 

3.2      Assist with the completion of the formal permit request submittals to all appropriate AHJ. 

3.3      Receive all plan review comments from the AHJ and coordinate formal responses with the A/E team.  See the permitting process all the way through to the issuance of all permits required to commence construction. 

 

4          Project Schedule & Contract

4.1       Coordinate the development of an appropriate AIA contract for execution with the Owner. 

4.2       Work with the subcontractors to establish and issue a formal Project Schedule to the Owner for review and approval.  This Schedule will become a formal exhibit to the AIA contract. 

4.3       Assist with the development of the AIA contract language so that it is mutually agreeable to all parties. 

4.4       Review the AIA contract in detail with the Owner prior to execution. 

 

5          Construction Management

5.1       Perform all required construction administration and project management including: 

5.1.1    Project Schedule coordination with subcontractors and facility staff 

5.1.2    Plan and implement a temporary location for compounding for the duration of the project, if required. 

5.1.3    Implementation of all required Interim Life Safety Measures and Infection Control Precautions in accordance with the facility’s Environment of Care guidelines. 

5.1.4    Request for Information (RFI) coordination for the Owner and Design Team 

5.1.5    Review of all Change Order requests and conditions with Design Team and Owner.  

5.1.6    Provide regular Status Reports to the Owner including photographic project documentation 

5.1.7    Progressive on site meetings and tours with the Owner as requested 

5.1.8    Monitoring and reporting of all required progressive Inspections by the AHJ.

 

6          Certification

6.1       Before the new compounding complex can be utilized, formal clean room certifications will be required.  This will be coordinated with a local certification company and at a minimum consist of:

6.1.1    Non-viable and Viable Particulate counts

6.1.2    Pressure Differential testing

6.1.3    Air Change calculations

6.1.4    HEPA filter leak testing

6.1.5    Issuance of formal ISO Class Certificates

 

7          Project Closeout

7.1      Coordination of Project closeout documentation including Maintenance & Operations Manuals

7.2      Staff training on the operation of all newly installed systems

7.3      Final turn over of the completed project to the Owner