590 BIOLOGY OF PNEUMOCOCCUS 



BULK STERILITY AND POTENCY TESTS 



As soon as the lot of serum is filtered, samples are removed for 

 sterility and potency tests and for tests of chill-producing prop- 

 erties, in case the latter test is to be performed on laboratory ani- 

 mals. Regulations of the National Institute of Health covering 

 the tests for sterility are included in the Appendix, page 662. 



It is necessary to determine the potency of antipneumococcic se- 

 rum prior to filling the final containers. These tests, as well as tests 

 on animals for chill-producing qualities, may be done conveniently 

 with samples taken from the bulk containers and while the tests for 

 sterility are being made. The methods employed have been de- 

 scribed in a previous section of this chapter. It is obvious that the 

 product must pass these tests satisfactorily before it is dispensed 

 into the final containers. 



DISPENSING AND LABELING 



After the serum has passed all the tests made on samples taken 

 from the bulk containers, it may be dispensed into final containers 

 for distribution. Sterile, rubber-capped vials or syringe ensembles 

 of a capacity never greater than the maximal dose for man are 

 used for the purpose. A convenient method of dispensing the bulk 

 product into the vials or syringes is briefly as follows : The serum 

 from the bulk container is forced by compressed air into a burette, 

 equipped with a specially designed filling device, which, by means 

 of a protecting bell or dome, covers the neck of the vial to be filled. 

 All openings are protected against air-borne bacteria by sterile 

 cotton air-filters. The entire filling apparatus must, of course, be 

 sterilized before use. As soon as the vial is filled with serum, a soft 

 rubber stopper is inserted, and sealed with a viscose cap or gelatin. 

 The bottling process should be conducted under strict aseptic con- 

 ditions in a room free from draughts and dust. 



When the lot of serum has been dispensed into the final con- 

 tainers, approved labels, on which are recorded the lot number of 

 the preparation, the potency for each type of antibody contained, 



