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Designing a CSP Facility

The design, construction, qualification, operation, and maintenance of a USP <797> compliant CSP pharmacy adequate to meet the current and foreseeable needs of hospital, clinical, and home healthcare institutions is a daunting proposition for many practitioners. Varying approaches have been proposed by numerous vendors, architects, and builders which are often extremely costly and may ultimately prove to be too simplistic or inadequate for their intended purposes. The correct design perspectives should, therefore, be maintained regarding your CSP pharmacy facility.

The CSP pharmacy, normally a clean space, is merely one component of the overall CSP process. It should be systematically conceptualized, designed, built, qualified, operated, and maintained in compliance with pertinent pharmacy standards and guidelines to meet the ongoing needs of your specific CSP process(es). Because a number of important operations must effectively mesh within the CSP pharmacy, proper planning for both current and expanded CSP operations is essential.

Recently, a number of low-cost, quick-upset, total CSP pharmacy projects were successfully undertaken by Lab Safety Corporation(1). The following is a summary of the design/build processes employed to assure success of the projects. This summary may be employed by practitioners to ensure the effectiveness of their proposed designs:

Demographics and Marketing

As the initial step to ensure operation of the CSP pharmacy will meet the current and ongoing needs of the institution, a Demographics and Marketing survey should be generated to analyze the needs of the institution in the current, projected intermediate, and long terms. Only through such analysis will the Director of Pharmacy and the Administrator be assured of the adequacy of the facility in meeting anticipated work and workload requirements for the foreseeable future.

Design Qualification (DQ)

The qualification of the design approach in accord with current and proposed pharmacy-practice standards and guidelines ('the Standards') should be carried out as the next step. A formal DQ should be generated by the Director of Pharmacy to identify the required materials and components of the design and to certify its operational compliance in all areas in accordance with the Standards.

The Design

Next, an appropriate design should be developed, including all structural, electrical, plumbing, HVAC, engineering controls, lighting, work-streaming, and waste-streaming components. The design must then be related to the DQ to ensure compliance with the Standards.

Installation Qualification (IQ)

Qualification of actual construction/remodeling of the facility and installation of the proper materials and equipment should then be carried out in an IQ. This document should completely document all final examinations, measurements, adjustments, and any variances to the design as related to the DQ. Successful completion of this document in accord with the design sets the stage for conduct of the OQ.

Operational Qualification (OQ)

Following completion of the IQ, the OQ is carried out to ensure and document the correct operation of all facility electrical, plumbing, mechanical, and process systems in accordance with the design. Successful completion of this document sets the stage for conduct of the PQ.

Process Qualification (PQ)

As the final qualification of the CSP process, the PQ establishes and documents the capability of the facility to support the process and to maintain the required environmental conditions while producing sterile preparations of the desired quality.

Policies and Standard Operating Procedures (SOPs)

Following completion of the PQ, a complete set of SOPs should be developed and periodically updated to assure continued operation and documentation of the CSP process in accordance with the design and PQ, thus closing the loop on CSP Process Quality. Ongoing operation and documentation in strict accordance with the final, updated SOPs ensures the safety, efficacy, manageability, and Continuous Quality Improvement (CQI) of the institutional CSP processes.

(1) Peters, G. F., et al., "Achievement of United States Pharmacopoeia Chapter <797> Compliance by a 35-Bed rural Hospital: A case Study." International Journal of Pharmacy Compounding, Vol. 11-6, 450-470, Edmond, OK. November/December, 2007.

Case History

 

The CSP pharmacy in the Advocate Illinois Masonic Medical Center, a 474 bed critical-care facility, was designed by Lab Safety Corporation.

ISO Class 5 Work Surface

The ISO Class 7 Critical Core includes 16 feet of ISO Class 5 unidirectional flow worksurface.

ISO Class 7 Critical Core

Dual pass-through boxes between the Aseptic Core and the large Anteroom facilitate separate throughput of routine and stat orders.

"At Advocate Illinois Masonic Medical Center Pharmacy, we have been using Lab Safety Corporation services for three years with excellent results. Lab Safety provided a design for a cleanroom/anteroom facility for our CSP preparation which is both USP <797> compliant, and conducive to an efficient operation.

Using specific indicators for
quality assurance, Lab Safety
worked with us to establish
a training program for our pharmacists and technicians
to demonstrate competency
in aseptic technique and compounding procedures.
We also relied on their expertise in high risk areas, such as chemotherapy preparation. Lab Safety's teaching materials were comprehensive and their staff was knowledgeable and easy
to work with. I would highly recommend Lab Safety products and services for any hospital or facility that prepares CSP’s."

Janet Jaramilla
PharmD., BCPS
Director of Pharmacy Services
Advocate Illinois Masonic Medical Center

View Facility Case History.

 

cGMP Qualification

 

View the OQ for a cGMP Cleanspace designed and qualified by Lab Safety Corporation.

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View the OQ for a cGMP manufacturer's multi-level cleanspace performed by Lab Safety Corporation.

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