Methods for sterilizing cross-linked gelatin compositions
Disclosed are methods for sterilizing cross-linked gelatin as well as to sterilized cross-linked gelatin. In particular, the methods of this invention employ E-beam sterilization techniques.
1. A method for sterilizing a cross-linked gelatin composition for use in vivo, comprising:
exposing the cross-linked gelatin composition to a sufficient dose of E-beam irradiation under conditions wherein said composition is sterilized and wherein said cross-linked gelatin composition retains a sufficient amount of fluid absorbability of about 35 grams of fluid per gram of gelatin.
2. The method of claim 1 wherein the cross-linked gelatin composition retains a sufficient amount of tensile strength.
3. A method for sterilizing a cross-linked gelatin composition for use in vivo, comprising:
exposing the cross-linked gelatin composition to a sufficient dose of E-beam irradiation under conditions wherein said composition is sterilized and wherein said cross-linked gelatin composition retains a tensile strength of about 2.5 lbs/in2.
4. The method of claim 3 wherein the cross-linked gelatin composition retains a sufficient amount of fluid absorbability.
5. A method for preparing a sterile, cross-linked gelatin composition in a packaging element, said cross-linked gelatin for use in vivo, the method comprising:
(a) selecting a packaging element;
(b) adding said cross-linked gelatin composition to the packaging element selected in (a) above; and
(c) exposing the packaging element formed in (b) above to a sufficient dosage of E-beam irradiation maintained at an initial fluence of at least 5 μCurie/cm 2 to sterilize both the packaging element and the cross-linked gelatin composition therein wherein the average bulk density of the materials comprising the packaging element is less than about 0.2 gm/cm 3 and wherein said cross-linked gelatin composition retains a sufficient amount of fluid absorbability and tensile strength.
6. A sterilized cross-linked gelatin composition characterized by a fluid absorbability of at least 30 grams of fluid per gram of gelatin and a tensile strength of greater than 2.0 lbs/in 2 .
7. The sterilized cross-linked gelatin composition of claim 6 wherein said composition has a fluid absorbability of at least 35 grams of fluid per gram of gelatin and a tensile strength of greater than 2.5 lbs/in 2 .
8. The sterilized cross-linked gelatin composition of claim 6 wherein said composition further comprises an antimicrobial agent, a growth factor, a thrombus enhancing agents or mixtures thereof.
9. The sterilized cross-linked gelatin composition of claim 8 wherein said antimicrobial agent is an antibiotic.
10. A method for preparing a sterile syringe comprising a cross-linked gelatin composition wherein said syringe is included in a packaging element which method comprises:
(a) selecting a syringe assembly comprising a holding chamber an injection port which comprising a luer hub and an ejection port which is attached to a cannula;
(b) adding to the holding chamber of said syringe a cross-linked gelatin composition in the form of a pledget;
(c) adding sterile saline to said holding chamber wherein sufficient amounts of said saline are added to hydrate said pledget;
(d) transferring the hydrated pledget into the cannula attached to the ejection port;
(e) combining at least a single syringe produced in (d) above into a packaging element;
(f) exposing the packaging element formed in (e) above to a sufficient dosage of E-beam irradiation maintained at an initial fluence of at least 5 μCurie/cm 2 to sterilize the packaging element and the syringe and the gelatin composition therein
wherein the average bulk density of the materials comprising the packaging element is less than about 0.2 gm/cm 3 and wherein said cross-linked gelatin composition retains a sufficient amount of fluid absorbability and tensile strength.