About Samson Medical Technologies
Medical Technologies, L.L.C. is a privately-held company focused on providing
hospital and alternate site pharmacists with injectable drug delivery systems
and programs designed to meet their unique needs. Samson Medical Technologies
is small enough to listen to customers and large enough to supply what pharmacists
Pharmacists Provide Impetus to Establish Samson Medical Technologies
During the 1990s, when Marvin Samson, a world-renowned expert in parenteral products, was President and Chief Executive Officer of a leading manufacturer of sterile antibiotics for injection, he was approached by pharmacists, representing many major institutions, to see if his company could provide pharmacy bulk packages containing several multiples of the prevailing package size.
These large hospitals recognized the advantages of administering intermittently dosed anti-infectives by syringe infusion. Having resolved the issues regarding the actual infusion using syringes, i.e., the availability of microbore tubing and appropriate infusion pumps, innovative hospital pharmacists began to seek means to enable preparation of sterile anti-infective powders into solutions suitable for syringe delivery.
It should be noted that at this time, the general practice for preparing such individual anti-infective dosage forms was to constitute a number of pharmacy bulk packages, pump their contents into a sterile empty bag and then withdraw a sufficient number of individual doses into syringes. Alternatively, following constitution of the powder, individual doses were aliquotted directly from the pharmacy bulk package into syringes. Some of the larger institutions were preparing 900 syringes of Cefazolin per day, requiring the use of 90 conventional pharmacy bulk packages, and they were very interested in minimizing the number of manipulations their process involved.
Mr. Samson established Samson Medical Technologies, L.L.C. to create a system that would enable the hospitals to prepare solutions, intended for use in syringe infusion, with a greater degree of safety, accuracy and ease than through the use of conventional pharmacy bulk packages.
As Mr. Samson traveled throughout the country holding meetings with hospital pharmacists, he solicited feedback on the most desired features and characteristics of a pharmacy bulk package. What he learned led to the specification of design parameters from which Samson Medical Technologies, in conjunction with its supplier, developed the SmartPak® system.
Design of SmartPak®
SmartPak® pharmacy bulk packages consist of two sterile bags; the inner bag, which is in contact with the sterile drug, is made of an additive-free polymer. This material has been employed successfully for many years, and its compatibility with many anti-infective powders has been firmly established. The inner bag is fabricated with two ports to facilitate the addition of diluents and withdrawal of constituted doses, respectively, consistent with the protocol utilized in the hospital pharmacy. Because this bag has a capacity of four liters, the sterile products pharmacist has a great deal of latitude in supplying the concentrations that are most appropriate for the patient population being served.
An outer bag protects the inner bag (and the material contained within) from light, moisture and oxidation. This bag is not in contact with the drug product. It consists of a laminated aluminum foil of four layers joined together, with the internal layer made of an additive-free polymer.
Features of SmartPak®
SmartPak® is compatible with commercially available pumps, tubing sets, syringes and filling systems. Independent studies have shown that replacing traditional 10-gram pharmacy bulk packages with one SmartPak® bag containing 300 grams of Cefazolin results in 45 minutes of savings in dose preparation time.
Benefits of SmartPak®
Additional advantages of the SmartPak® system include the following:
- It is a closed system for reconstitution and aliquotting, utilizing disposable components.
- Reduced handling, with one bag equivalent to up to 30 typical pharmacy bulk packages.
- Enhancement of sterility assurance through fewer manipulations.
- Four liter capacity provides ability to vary concentration, e.g., for pediatric and/or geriatric patients
- Unbreakable plastic bag reduces risk of injury to practitioner and loss of drug.
- Space-saving package allows a typical hospital to store a four-month supply in one drawer.
- Following use, the flat configuration occupies less space in dumpster than glass, reducing trash removal cost.
Marvin Samson says, "We designed our packaging system to reduce the number of manipulations for constituting and aliquotting sterile products, shorten the time needed to prepare individual doses and reduce opportunities for touch contamination. It is safe, user-friendly and environmentally sound."
Cefazolin for Injection, USP is currently available in 100 and 300 gram SmartPak® pharmacy bulk packages and carries full product labeling. Cefazolin is the most widely used first generation cephalosporin in the U.S. Samson Medical Technologies is looking forward to approvals of additional products in the near future.