CAPS® Believes Patient Safety is Job One
CAPS Quality Assurance program is designed to ensure compounded sterile preparations (CSP) of the highest quality. Our goal is to maintain the most comprehensive and continuous quality assurance program in the industry.
CAPS employs a Quality Assurance (QA) team of chemists, microbiologists, and on-site quality personnel.
The CAPS Quality Assurance program provides a framework for integrating measurement, audit, evaluation, and improvement systems. These systems are governed by a strict set of standard operating procedures that are supported by didactic learning modules and skill-based training.
All 503A CAPS pharmacies admix in a laminar flow, ISO Class 5 zone, within an ISO Class 7 buffer zone. Air testing for particulate and bioburden is performed weekly. Employee fingertip testing is performed weekly. Media-fill validation of compounding processes is performed semi-annually. Cleandown and line clearance are performed between every drug, every day. CAPS uses rapid sterility testing technology as an end product test per USP<71>. Quality Assurance reports are provided to our customers on a quarterly basis.
Some of the many CAPS Quality Assurance Features:
- Sterility testing featuring the BacT/ALERT® microbial detection system
- Comprehensive environmental monitoring
- Media-fill validation
- Barcode automation
- Beyond use dating (BUD) based on real time studies using stability indicating methods, container closure integrity testing (CCI), and daily process sterility testing
- Advanced personnel training and education
- Quality assurance reports delivered to you quarterly
CAPS’ policy is to use FDA-approved, commercially available, sterile drugs for admixing. In cases where FDA-approved sterile drug ingredients are not available, vendor qualification, including regulatory compliance audits, are completed for any Active Pharmaceutical Ingredients (API) used in non-sterile to sterile compounding. All lots of API provided by qualified vendors are tested for chemical identification, impurities, heavy metals, and endotoxin per current USP/NF standards prior to release for use in any CAPS facility.
CAPS high-risk non-sterile to sterile compounding process is validated every six months through a media-fill validation in accordance with USP <797> and FDA Guidance. Each CAPS employee who participates in non-sterile to sterile compounding must complete a bi-annual media-fill validation. Once the solutions are prepared from the raw materials, they are sterilized using a cold filtration process in which they are passed through a 0.2μm pharmaceutical grade sterilizing filter into the final sterile container within an ISO Class 5 Laminar Airflow Work Station (LAFW).
All sterile solutions that are compounded from non-sterile components undergo validation testing before a CAPS facility may use the solution. All sterility and chemical testing procedures are validated and performed according to current USP/NF standards. These sterile filtered solutions are quarantined until quality assurance testing, including sterility testing, is complete as required by CAPS Standard Operating Procedures and USP <797>.
Each batch is reviewed by a Registered Pharmacist and the on-site independent Quality Assurance personnel. No lot may be released for use unless all tests performed return results within specifications and the on-site independent Quality Assurance personnel has authorized the batch for release.
Quality Assurance tests completed for each batch solution compounded from non-sterile powders:
- Mixing vessel/liner integrity testing
- Filter integrity testing (Bubble Point Test)
- Yield verification, label ID verification, visual appearance
- LAL (Endotoxin testing per USP/NF)
- Sterility testing using Rapid Sterility Method BacT Alert System
- Particulate matter test (per current USP/NF HIAC)
- Chemical identifications, pH, and concentration measurements per USP