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CAPS® Frequently Asked Questions

   

CAPSLink Online allows for secure ordering via the web, with builtin safety checks throughout. There is no equipment to install, so you can be setup to order your prescription solutions from CAPS in as little as a day’s time.

Pharmacists review orders upon receipt, and prepare your order using our automated compounding process and a barcoded manual-add-system (MAS) to verify ingredient accuracy.

CAPS admixes in a laminar flow, ISO Class 5 zone, within an ISO Class 7 buffer zone.

Air testing for particulate and bioburden (bacteria, yeast and mold) are performed weekly.

Employee fingertip testing is performed weekly.

Media fill validation of our compounding process are performed semi-annually.

Cleandowns and line clearance are performed between every drug, every day.

Stability is more than a simple potency test at CAPS. Our guaranteed BUD assigned to compounded solutions is based on the most advanced techniques in the industry.

  • CAPS uses method development/validation procedures to ensure no false positives from impurities when testing for Stability. Our protocols measure for concentration, pH, color, clarity, and particulates.
  • Container Closure Integrity (CCI) testing is performed on containers (bags, syringes, devices, vials) to demonstrate that sterility is maintained over the shelf life of the product.
  • Each CAPS pharmacy utilizes a daily process sterility test method incorporating the membrane filtration technique and a 14 day incubation with conditional release. This technique meets USP 71 requirements with correct sample size and volume.
  • A defined product withdrawal and destruction process is in place in the event of a positive growth.

CAPS provides professional, high-contrast labeling based on FDA and ISMP standards for tall man lettering, and color coding using ASTM standards where appropriate. A specific product code has been assigned for each anticipatory solution based on drug concentration, diluent, and container. Product codes for controlled substances are listed with the DEA.

CAPS follows a USP <797> compliant compounding process for high risk compounded solutions. The process includes end-product testing of every batch utilizing the membrane filtration technique or the FDA Approved BacT Alert testing system, bubble-point testing of the filter, and a full 14 day quarantine to ensure chemistry, sterility and other release criteria. High-risk solutions are not released for use unless they pass all specification tests.

CAPS employs licensed pharmacists, chemists, microbiologists, and certified technicians, including Quality Assurance personnel who are accountable independently from the admixture staff.

CAPS is FDA registered, DEA registered and maintains all appropriate licenses with State Boards of Pharmacy.

A quarterly QA report is provided to each customer and employee training reports are available upon request.