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QUALITY ASSURANCE ISSUES
June 6, 2007
 

HISTORY and EXPERIENCE
The Compounder pharmacy has been in business in Aurora, Illinois since April 1983. The owner/operators are Patricia and Larry Frieders, both were licensed to practice pharmacy in 1971 and have been actively engaged in the art and science of custom compounding from the very beginning. In addition to their pharmacy education, both Larry and Pat have advanced academic degrees (Larry: Northwestern University and Loyola University, Chicago | Patricia: Aurora University).

Patricia was the pharmacist supervisor at the University of Illinois Hospital in Chicago. Larry supervised the first sterile compounding area at Cook County Hospital in Chicago. As the director of pharmacy at Jackson Park Hospital, Chicago, Larry initiated a sterile compounding service and later was the director of the central sterile services during the construction phase of the new department.

Both Pat and Larry have extensive experience with sterile compounding and they managed their own home infusion practice from1986 to 2006.

In all their years of experience not a single compounded product has been found to be contaminated.

How do they know that? All preparations and systems are tested.

Batch Testing
Every batch of compounded sterile preparation is autoclaved or filtered through multiple sterilizing filters and a test device. The filters are tested immediately after use for patency (referred to as a "bubble test"). A test device is filled with an approved growth media and placed in an incubator. It is evaluated daily for up to two weeks. Our policy states that if any growth is detected the batch is pulled and every recipient is notified. To date, no batch has ever been rejected.

Batch Testing Accuracy
How does The Compounder staff know that their internal batch testing is accurate? Samples are also selected and sent to outside testing labs. The results from those labs attest to the potency and sterility of the preparations and verify the internal batch testing. External labs are also used to verify that there is no pyrogen or fungal contamination.

RECEIVING WHAT YOU'VE ORDERED
How can a customer be sure that what they receive is what they order? To start, all ingredients are purchased from FDA approved chemical vendors and certificates of analysis are available for every lot.

Every batch of compounds begins with a written formula sheet - a recipe for making the compound. The formulas are generated by a pharmacist and checked by another. The technicians remove the appropriate ingredients from stock. The chemicals are measured and then checked by the compounding pharmacist on duty. The balances used are electronic and there is a printout of each weight. The balances are tested and certified by an outside company annually. Balances are housed in special draft-free cabinets that protect against breezes and assure that the workers are handling powders in the safest environment possible. The pharmacist compares the actual ingredients and weights with the formula sheet. Each lot number is recorded and the formula sheet is signed by both the technician and the pharmacist. Every compounding formula sheet is maintained on file at The Compounder along with all other documentation that pertains to that compound.

The formula sheet contains specific, step-by-step instructions for assembling and preparing the compound. The technicians and pharmacists put the formula together and the final product is again checked by a compounding pharmacist. Each compound is visually inspected and the final product is weighed or measured according to need. Validating checks are part of every compound including viscosity, clarity, uniform dispersion of suspensions, weight variance, and volume accuracy. Every compound is checked numerous times, always by more than one person.

Capsules are assembled in a special capsule filling device and batches are checked for capsule-to-capsule weight consistency. Weight tests usually run under 1% variance. That is significantly better than accepted manufacturing standards. We have the data to prove this.

Injections are assembled in the laminar flow area and inspected for complete dissolution and clarity or even distribution. The assembled formula is transferred to a sterile room where it is final-filtered, tested and packaged into vials, syringes, or droppers. The sterilizing filters are checked for patency immediately after the compound is filtered. If the patency check should fail the batch is processed again.

No compound leaves The Compounder pharmacy until the
pharmacists are sure it is perfect.

USP <797>  THE Final Word on Sterile Compounding
The Compounder professionals have incorporated the new USP <797> standards. Actually most of the processes were in place before the standards were published. There are three laminar flow hoods and two powder containment hoods that keep our air as clean as possible. Standards require that our clean room has less than 10,000 particles per cubic meter.  Our room and ante-room test out far below that number. Our hood tests at less than 10 particles - the standard is 100. We have test data to substantiate this claim.

Our staff is tested regularly to make sure the containment systems are efficient. All air handling equipment is tested and certified by an outside service twice a year. Room air throughout the lab is filtered through high efficiency pleated filters. There are room HEPA units and electrostatic air cleaners. Humidity is maintained above 30% year round.

STAFF PROTECTION also PROTECTS OUR CUSTOMERS
The Compounder provides uniforms, hair coverings, lab coats, safety goggles, gloves, shoe covers, and masks to the staff and maintains them for the employees. We make sure that our employees neither bring contaminants in from the outside nor take any potentially harmful ingredients home with them on their clothes.

Floors in the laboratory are cleaned regularly. The sterile preparation room is cleaned with a disinfectant solution according to a written schedule. The disinfectant is changed quarterly to eliminate the risk of resistant organisms. Walls and ceiling are cleaned with disinfectant monthly. All hoods and work surfaces are cleaned and disinfected daily and throughout the work day.

The glassware and equipment are cleaned after every use in a high-temperature dishwasher. All items that require hand washing are rinsed with distilled water and air dried in our clean environment before being returned to storage. Storage areas are closed to reduce the potential for contamination with dust.

The Compounder management is committed to formulating the finest custom preparations possible and invests heavily in technology and services that assure the compounds meet the highest standard.

The labs may be inspected any time during regular business hours (Monday through Friday, 9:00 am to 5:00 pm) without advanced notice. The Compounder doesn't need time to prepare for a visit or inspection. The compounding labs are ready all the time.

The Compounder complies with the most current HIPAA (Health Insurance Portability and Accountability Act) rules and regulations.  Visitors may be asked to sign a confidentiality agreement if they will be touring an area where patient information may be visible.