Our trained staff specializes in the preparation of Intrathecal Pain Pump refill syringes. Many compounding pharmacies prepare the intrathecal
pump refill syringes but few possess the proper facilities, personnel and procedures to safely compound these high-risk
prescriptions. According to new USP Guidelines <797>, pharmacies preparing these highly specialized and high-risk
prescriptions should meet minimum facility guidelines (see inset).
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Our state-of-the art facility exceeds these standards, including our ISO Class 7 cleanroom facility. The mixing chamber
within this facility contains our ISO Class 5 LAFWs. This type of setup should be the minimum criteria for compounding
laboratories preparing intrathecal medications.
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Routine laboratory testing of our sterile products both by in-house testing equipment and by third-party analytical testing
laboratories complements our superior facility, adding further confidence to the safety and quality
of our products.
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Using only the highest quality USP-grade pharmaceutical chemicals, our pharmacy staff will prepare your intrathecal refill
medications and ship or deliver them when you need them. Each prescription is individually sealed in a
tamper-proof foil pouch, with extra labeling included for use in the patient's chart.
For our clients' convenience we have provided an online order form that can be printed out
for faxing to our laboratory. Just click on the link.
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Primary environmental control must provide at least ISO class 5 quality of air to which sterile ingredients and components of
compounded sterile products (CSPs) are directly exposed ... CSP work environment is designed to have the cleanest work surfaces
(horizontal or vertical clean benches [LAFWs], biological safety cabinets, or isolators) located in a buffer area, which is preceded
by an anteroom that provides a clean area for donning personnel barriers ... buffer or clean-room areas in which LAFWs are located are
to provide at least ISO class 8 air quality.
(Excerpt from USP General Chapter <797>)
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