Sterile Compounding
Triangle Compounding routinely prepares a wide variety of sterile products including:- Intrathecal Pump
Reservoir Medications

- Trimix Injections
- PZI Insulin
- Ophthalmic Drops and Injections
- Prialt (We are an Elan Pharmaceuticals Certified Site)
Making sterile products is the most critical and difficult type of compounding.
Dr. Loyd V. Allen, Jr., Ph.D., R.Ph, Editor in Chief of the International Journal of Pharmaceutical Compounding, has developed a list of questions patients and providers should consider when selecting a compounding pharmacy, particularly one that makes sterile products:
Click on each of the items to learn how Triangle Compounding complies:
* Passed an extensive onsite inspection.
* Meets or exceeds rigorous national standards.
* Uses only the highest quality chemicals and equipment.
* Maintains a continuous quality improvement system.
* Highly qualified staff.
You can review our accreditation report here.
PCAB (Pharmacy Compounding Accreditation Board) is a not-for-profit corporation formed by eight national pharmacy organizations that recognize the need for national standards for compounding pharmacy. Each of the member organizations has one representative on the board:
American College of Apothecaries
American Pharmacists Association
International Academy of Compounding Pharmacists
National Association of Boards of Pharmacy
National Community Pharmacists Association
National Council of State Pharmacy Association Executives
National Home Infusion Association
United States Pharmacopeial Convention (USP)
The United States Pharmacopeia sets
standards for quality medicines, dietary
supplements and food ingredients wordwide.
Triangle Compounding is compliant with applicable USP standards. The additional items in this table detail how Triangle Compounding addresses some of critical requirements of USP 797 including:
*Quality Assurance/Quality Improvement practices appropriate to each Risk Level of medications prepared.
*Verification of compounding accuracy and sterilization.
*Personnel training and evaluation in aseptic techniques.
*Environmental quality control.
*Finished product release tests and checks.
• Triangle Compounding prepares
all sterile products in an ISO Class 5 cleanroom
as required by USP 797.
• All weighing and manipulation of ingredients also occurs in a separate ISO class 5 area, separated from the sterile manipulation area by a barrier and positive pressure.
• Triangle Compounding maintains an array of state of the art equipment including computerized autoclave, microprocessor controlled convection oven, USP quality water system, laboratory grade dishwasher with USP quality water supply, electronic pH meters and many others.
Beyond State of
The Art
• Barcode Readers,
Computers and Scales work together to improve
accuracy, prevent errors and capture important
information.
• All formulas are computer based.
• Barcode scan assures the chemical being used
matches the one required by the formula.
• The scan also records the lot number and expiration
date.
• Scales and computers interface to assure the amount
weighed is within 5% of the amount required.
• Detailed data about any compound, including
dispensing data and shipping status is instantly
available electronically.
•Internal: Sterility Testing using dual media (tryptic soy broth and sodium thioglycollate) per USP guidelines.
•Internal: Endotoxin testing of sterile products per USP guidelines.
•External: Samples are sent to an outside laboratory for potency analysis.

Triangle Compounding’s policies and procedures have been reviewed by PCAB and found to meet their extensive requirements.
Can we observe compounding personnel at work?
Do the personnel appear competent from observation and questions asked?
Is the pharmacy clean and well organized?
These questions are best addressed with an on site tour. We invite you to schedule an on-site visit.