On occasion, doctors and clients request information about our Clean Room quality standards and we are always pleased to share our procedures, test results and maintenance records. We like to show off.
Are we PCAB accredited?
Do we use a glove box?
Absolutely not. Glove boxes are amazingly inefficient and some regulations actually prohibit their use, especially if moved around on wheels.
What equipment do we use?
- We utilize a custom built 18′ x 24′ clean room facility erected by Pat Travis from Travis Clean Air. This room contains a 9′ x 24′ sterile product compounding area, a 6′ x 9′ ante/gowning room, a 5′ x 9′ hazardous compounding room, and our main 9′ x 13′ clean buffer room where final sterilization takes place. The clean buffer room contains two laminar flow hoods in addition to the two ceiling mounted 2′ x 4′ HEPA filters, with a recirculating air conditioning system. Our ante room contains a 2′ x 4′ HEPA filter, and in our hazardous compounding room a 2′ x 2′ HEPA filter.
- Clean buffer room air is circulated out into the ante room, through a prefilter and into an air conditioning unit, and then back into the main HEPA filters in the ceiling. Ante room air and hazardous room air are never reintroduced back into the clean buffer room environment.
- All rooms are sealed under positive pressure that is documented, along with room temperature and humidity, daily.
- Our laminar flow hoods are certified twice a year by Northern Air Flow.
What are we wearing?
Staff wear freshly laundered scrubs suits that we supply. We gown according to the strictest measures, using sterile Kimtech PURE A5 gowns and hoods with built in masks. We use sterile Bioclean Ultimate ASTM-D6978-05 rated gloves. All hair is covered, including facial hair.
Staff wear special shoes that we supply. They are covered with approved shoe covers. Masks, gowns, gloves, and shoe covers are disposed of after each use.
How do we train our staff?
We combine our in house certification program with the Valiteq Aseptic Technique Verification System. In addition to the traditional training exercises, we also perform routine media fill tests, process validations and outside potency/sterility testing.
How do we ensure sterility?
In addition to in house media testing and specific product testing performed by outside labs, such as Eagle Analytical and Compounder’s International Analytical Laboratory, we perform in house environmental monitoring on our equipment and room on a weekly basis. Our floors, which are given the most leeway in regards to number of colonies acceptable, routinely test at zero alongside our hood surfaces.
In addition to touch plate testing, we perform monthly air tests in specific locations throughout our facility. We also enlist the help of Northern Air Flow in performing microbial air tests on an annual basis.
Do we do any product testing?
We test our staff, both with internal test systems and by sending samples to outside laboratories that ensure and verify our internal testing. Numerous samples are sent out each month and tested for active ingredient potency and/or sterility and endotoxin content. We use multiple laboratories so we are constantly cross-checking one with the other – and against our internal tests.
Here are just a few tests of some of our products, including sterility and/or potency. We don’t just test our injections, our capsules and creams and suppositories are also tested every month.
What about cleaning?
The hoods are sanitized upon entry using a Sporocide (Veltek Associates Inc. Decon-Spore 200 Plus) or a Quaternary Ammonium Compound (Veltek Associates Inc. Decon-Quat 200 C, also known as a QUAT) (daily) and the floors are sanitized daily, both with a Sporocide (once weekly) and a QUAT (daily). The walls and ceilings are cleaned weekly with the same two rotating chemicals we use on our hood surfaces and floors, with a follow up rinse with sterile isopropyl alcohol.
We use lint-free towels and never allow any cardboard into any of the rooms.
What kind of test results do you need?
We can provide copies of air testing, sample testing, sterility, in-house test results, and so on. The Compounder is a high class operation and we are not afraid to publish our results. All of this testing and processing costs a lot of time and money. We do it so we can assure our preparations are as good as they can be.
You can always find it cheaper. You will never find it better.