Methods and systems for treating medical devices and fluids
A processing method and technology for medical devices, which are applied in pharmaceutical formulations, medical preparations containing active ingredients, and disinfection, etc., can solve the problems of complex technology, ineffectiveness, and expensive biological preparations.
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Embodiment 1
[0037] Water and aqueous solutions (comprising LPS with various sources of endotoxin) were exposed to calcium stearate [CaSt] (in powder suspension form) and exhibited reduced LPS or alternatively did not exhibit any detectable LPS (effect depending on CaSt dose). Various amounts of calcium stearate powder (PMC BIOGENIX, <21.8 microns, vegetable-based) were added to sterile test tubes. Add 5 mL of an aqueous solution of known endotoxin concentration (formed by doping endotoxin-free water with an aqueous solution of known endotoxin concentration) to each tube, vortex vigorously (1 min) using a Fisher Scientific digital vortex mixer, and then placed in a warm water bath (37°C) for 1 hour. After 1 hour, the tubes were removed from the warm water bath and vortexed vigorously (1 minute). Extract the solution using a sterile syringe with a needle without removing the calcium stearate. The solution is then tested for endotoxin levels. The kinetic chromogenic method for endotoxin ...
Embodiment 2
[0048] Example 2: Suture Testing in Aqueous Suspension
[0049] Suture treatment in aqueous CaSt suspension was performed as follows: The sutures used were (Polyglactin 910) suture, made of a copolymer containing 90% glycolide and 10% L-lactide, size 1, 27 inches long. The endotoxin source used was stagnant (or stagnant) rainwater (SRW) and diluted with LRW to obtain a concentration of 3980 EU / mL. Endosafe LAL Reagent Water (LRW) manufactured by Charles River Laboratories of Charleston S.C. was used. The calcium stearate used is PMC BIOGENIX, <21.8 microns, vegetable based).
[0050] Eight sutures were placed in the tube with LPS (endotoxin) for 10 minutes at a time. Sutures were allowed to dry for 20 minutes and then placed in round bottom test tubes. A 5% by weight suspension of CaSt in LAL Reagent Water (0.5 g CaSt in 10 mL LRW) was prepared. One suture was placed in each tube and vortexed in the solution for approximately 10 seconds. The sutures were removed and dr...
Embodiment 3
[0059] Example 3: Suture Testing in Organic Solvents
[0060] Medical devices (absorbable sutures as an example) were contaminated with LPS and then exposed to CaSt in a non-aqueous solvent, and then tested for LPS, a significant decrease in LPS concentration was detected.
[0061] The absorbent will be made from a copolymer containing 90% glycolide and 10% L-lactide (Polyglactin 910) sutures (size 1, length: 27 inches) were exposed to a solution containing LPS (endotoxin) (9 strands of Vicryl sutures were immersed in an endotoxin-containing solution (SRW, concentration: 3980EU / mL) for 10 minutes). Sutures were air dried in a vented chemical fume hood for 20 minutes, then placed in round bottom test tubes and dried. Sutures were then dipped in CaSt-containing ethyl acetate (EtAc), vortexed briefly for 10 seconds, dried in a vented chemical fume hood for 20 minutes, and then extracted from endotoxin-free water at ambient temperature. Sutures extracted in endotoxin-free w...
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