Method for destroying microbial contamination in protein materials

Claim 1

A method for destroying microbial contamination in protein material and rendering such material relatively free from such microbial contamination, said method comprising: (a) selecting protein material derived from or contained in (1) animal or human body fluids which perform a biological function, or (2) animal or human body cellular tissue which performs a biological function, or (3) protein material grown in or derived from an in-vitro environment and which performs a biological function, (b) reducing the temperature of such selected protein material to the freezing point of such protein material when in a non-lyophilized state, and reducing the temperature of such protein material when in a lyophilized state to a temperature of at least -3 degrees C., (c) applying gamma radiation to said material at such reduced temperature and which temperature remains relatively constant during irradiation and where the gamma radiation is irradiated in a relatively constant rad amount during irradiation but which is sufficient to destroy substantially all microbial contamination in such protein material without substantially reducing protein efficacy, to thereby provide a protein material relatively free of microbial contamination and which still exhibits substantial biological efficacy.

Claim 2

A method for destroying microbial contamination in protein material and rendering such material relatively free from such microbial contamination, said method comprising: (a) selecting protein material derived from or contained in (1) animal or human body fluids which perform a biological function, or (2) animal or human body cellular tissue which performs a biological function, or (3) protein material grown in or derived from an in-vitro environment and which performs a biological function, (b) reducing the temperature of such selected protein material to the freezing point of such protein material when in a non-lyophilized state, and reducing the temperature of such protein material when in a lyophilized state to a temperature of at least -3 degrees C., (c) applying gamma radiation to said material at such reduced temperature and which temperature remains relatively constant during irradiation and where the gamma radiation is irradiated in a relatively constant rad amount during irradiation but which is sufficient to destroy substantially all microbial contamination in such protein material without substantially reducing protein efficacy, to thereby provide a protein material relatively free of microbial contamination and which still exhibits substantial biological efficacy.

Claim 11

A method for destroying microbial contamination in protein material and rendering such material relatively free from such microbial contamination, said method comprising: (a) selecting protein material derived from or contained in extra-cellular animal or human body fluids and which performs a biological function, (b) reducing the temperature of such body fluids at least to the freezing point of such fluids, and (c) applying gamma radiation to said material at such reduced temperature and which temperature remains relatively constant during irradiation and where the gamma radiation is irradicated in a relatively constant rad amount during irradiation of at about 5,000 rads to destroy substantially all microbial contamination in such protein material without substantially reducing protein efficacy, to thereby provide a protein material relatively free of microbial contamination and which still exhibits substantial biological efficacy.

Claim 12

A method for destroying microbial contamination in protein material and rendering such material relatively free from such microbial contamination, said method comprising: (a) selecting protein material derived from or contained in extra-cellular animal or human body fluids and which performs a biological function, (b) reducing the temperature of such body fluids at least to the freezing point of such fluids, and (c) applying gamma radiation to said material at such reduced temperature and which temperature remains relatively constant during irradiation and where the gamma radiation is irradicated in a relatively constant rad amount during irradiation of at about 5,000 rads to destroy substantially all microbial contamination in such protein material without substantially reducing protein efficacy, to thereby provide a protein material relatively free of microbial contamination and which still exhibits substantial biological efficacy.

Claim 18

A method for destroying microbial contamination in protein material and rendering such material relatively free from such microbial contamination, said method comprising: (a) selecting protein material derived from or contained in (1) animal or human body fluids which perform a biological function, or (2) animal or human body cellular tissue which performs a biological function, or (3) protein material grown in or derived from an in-vitro environment and which performs a biological function, (b) reducing the temperature of such selected protein material to the eutetic point temperature of such protein material when in a non-lyophilized state, and reducing the temperature of such protein material when in a lyophilized state to a temperature equivalent to a eutectic point temperature if such material were in a non-lypholized state, (c) applying gamma radiation to said material at such reduced temperature and which temperature remains relatively constant during irradiation and where the gamma radiation is irradiated in a relataively constant rad amount during irradiation which is sufficient to destroy substantially all microbial contamination in such protein material without substantially reducing protein efficacy, to thereby provide a protein material relatively free of microbial contamination and which still exhibits substantial biological efficacy.

Claim 19

A method for destroying microbial contamination in protein material and rendering such material relatively free from such microbial contamination, said method comprising: (a) selecting protein material derived from or contained in (1) animal or human body fluids which perform a biological function, or (2) animal or human body cellular tissue which performs a biological function, or (3) protein material grown in or derived from an in-vitro environment and which performs a biological function, (b) reducing the temperature of such selected protein material to the eutetic point temperature of such protein material when in a non-lyophilized state, and reducing the temperature of such protein material when in a lyophilized state to a temperature equivalent to a eutectic point temperature if such material were in a non-lypholized state, (c) applying gamma radiation to said material at such reduced temperature and which temperature remains relatively constant during irradiation and where the gamma radiation is irradiated in a relataively constant rad amount during irradiation which is sufficient to destroy substantially all microbial contamination in such protein material without substantially reducing protein efficacy, to thereby provide a protein material relatively free of microbial contamination and which still exhibits substantial biological efficacy.