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Carol, our quality control pharmacist is holding our policy and procedure manual that tells us step-by-step how to do everything that we do in the compounding lab from how to use, maintain and clean the equipment to step-by-step instructions on how to make every single dosage form that we compound which include capsules, creams, ointments, gels, suppositories, enemas, oral solutions and suspensions, sublingual (under-the-tongue) tablets, nasal sprays, ear drops, transdermal pain gels and sterile injectables.
Quality compounding begins with quality chemicals that meet or exceed stringent pharmaceutical specifications. Inexpensive chemicals that are past or near expiration, with no independent verification, are available, but unacceptable at The Compounding Shoppe. Our chemicals come from FDA-inspected chemical suppliers.
Upon receipt, all chemicals are placed into quarantine until their certificate of analysis is verified by one of our pharmacists. Then the pharmacist creates a bar code to place on the container and adds it into inventory.
All of our formulas are stored electronically in our pharmacy computer system. When we need to compound one of the formulas, we pull up an electronic log sheet in the lab where the barcode reader and even the electronic balance are all integrated into the computer system to literally create an error-proof compounding lab.
Every chemical receives a unique barcode label when it is entered into our inventory. Before weighing, the barcode is scanned to make sure the correct chemical is about to be weighed.
Any compounding that involves working with powders is done in a containment hood that you see our technician Pam working in. Working with the powders inside these hoods (we have 4 of them) protects you from receiving a compounded medication that is cross-contaminated with ingredients from someone else's medication that was made just before yours was made. Our policy is to clean the hoods between each project to prevent such cross contamination.
NTEP-certified balances like this are used at each weighing station in the compounding lab. To assure the balance is weighing properly they are internally calibrated every morning and externally calibrated weekly.
The electronic mortar and pestle has become a major work horse in our compounding lab. We use it to mix creams, ointments, gels, oral suspensions and even powders used to make capsules. When we send our capsules off to Eagle Analytical Laboratories for independent quality testing, they always comment on the great quality of our powder mixes!
One of our technicians, Maria running a finished cream through an ointment mill. This reduces particle size resulting in very smooth and pharmaceutically elegant creams, ointments, gels. It can also be used to remove any "grittiness" from oral suspensions.
We are serious about sterile compounding. That is why we use a class 10 sterile isolation barrier (glove box) that exceeds the USP requirements by a factor of 10. Most pharmacies do their sterile compounding in an open-face class 100 hood. Most also weigh the ingredients for their sterile products in the class 10,000 cleanroom environment. All of our sterile weighing is done inside the isolation barrier.
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