PRODUCTION OF ANTIPNEUMOCOCCIC SERUM 591 



and the expiration date set by federal regulation are affixed to the 

 bottles. 



STERILITY TESTS ON FINAL CONTAINERS 



The method required by the National Institute of Health is de- 

 scribed in the Appendix, page 662. 



SAFETY AND IDENTITY TESTS 



Using the serum from one of the labeled, final containers, the 

 routine safety test in a guinea pig is made (see page 588 of this 

 chapter). 



IDENTITY TEST 



For this purpose, the simple precipitin test with type-specific 

 pneumococcal capsular polysaccharide homologous for the types 

 of antibody contained in the product is satisfactory. 



RECORDS 



It is important that complete records be made of every lot of 

 antipneumococcic serum produced. These are conveniently kept on 

 a separate form for each lot, suitable to the needs of the labora- 

 tory, and giving in detail all essential data on each step in the 

 process of manufacture, with the initials of the person making each 

 entry. 



In the United States, for laboratories operating under federal 

 license, it is necessary to submit to the National Institute of 

 Health protocols of potency tests together with two of the final 

 containers of each lot of serum to be distributed for therapeutic 

 use (see Appendix, page 661). 



REGULATIONS GOVERNING ANTIPNEUMOCOCCIC SERUM 



In the United States, control over biological products con- 

 cerned in interstate commerce is maintained by the Treasury De- 

 partment through the Public Health Service which, from time to 

 time, formulates or revises and issues regulations. Antipneumococ- 



