Pancreatin and method for reducing the viral and microbial contamination of pancreatin

A method for producing pancreatin with reduced viral and microbial contamination, comprising the steps of:

• (a) providing pancreatin in solid form with a residual moisture of 0.5 weight percent (weight %) or less based on the pancreatin provided;
• (b) subjecting the pancreatin filter cake provided in step (a) to a heat treatment at a temperature of 84° C. and below obtaining heat treated pancreatin;
• wherein
• the biological activity of the heat treated pancreatin obtained in step (b) corresponds to at least 50 percent (%) of the biological activity of the pancreatin provided in step (a);
• and
• the viral infectiousness of the heat treated pancreatin obtained in step (b) has been reduced by a factor of more than 1 log10 in comparison with the viral infectiousness of the pancreatin provided in step (a).

A pancreatin product produced by the following steps:

• (a) providing pancreatin in solid form with a residual moisture of about 0.1 to 0.3 weight percent (weight %) or less based;
• and
• (b) subjecting the pancreatin provided in step (a) to a heat treatment at a temperature of 80° C. or less, obtaining heat treated pancreatin having a biological activity corresponding to:
• (1) a bacterial load of less than 500 KBE/g;
• (2) reduced viral contamination by a factor greater than 1 log10 as compared to the viral contamination of the pancreatin;
• and
• (3) biological activity of at least 90 percent (%) of the biological activity of pancreatin.

A pancreatin product with reduced microbial and viral contamination produced by the following steps:

• (a) reducing pancreatic glands by comminuting;
• (b) subjection of the comminuted pancreatic glands to autolysis obtaining pancreatin;
• (c) filtering the pancreatin to obtain a sieve filtrate;
• (d) precipitation of enzymes contained in the sieve filtrate obtained by the filtration;
• (e) filtration of the enzymes of step (d) to obtain pancreatin in solid form;
• (f) grinding the pancreatin in solid form;
• (g) drying the pancreatin in solid form by vacuum to a residual moisture of 0.5 percent weight (weight %) in relation to the provided vacuum-dried pancreatin in solid form;
• and
• (h) subjecting the pancreatin in solid form to a heat treatment at a temperature of 84° C. or less, obtaining heat treated pancreatin.

A pancreatin product with reduced microbial and viral contamination produced by the following steps:

• (a) providing pancreatin glands with a residual moisture of about 0.5 weight percent (weight %) or less based on the weight of pancreatin provided;
• (b) mincing the pancreatic glands;
• (c) subjecting of the minced pancreatic glands to autolysis to obtain an intermediate product;
• (d) filtering the intermediate product, obtaining a sieve filtrate with pancreatin having a microbial load of less than 500 KBE/g;
• (e) precipitating the enzymes contained in the sieve filtrate to obtain a mixture;
• (f) filtering of the mixture to obtain a pancreatin filter cake;
• (g) grinding the pancreatin filter cake;
• (h) drying the pancreatin filter cake grounds by vacuum to a residual moisture of between about 0.1 and about 0.3 percent weight (weight %) in relation to the provided vacuum-dried ground pancreatin filter cake;
• (i) subjecting the vacuum dried untreated pancreatin to a heat treatment at a temperature of between about 70° C. and about 80° C. to obtain a heat treated pancreatin filter cake;
• and
• (j) grinding the heat treated pancreatin filter cake to a pancreatin end product.