Vaccine.pptx use for general flow chart of bacterial c=vaccine

Imp for Vaccine Mfg.

1. Question:-Write a general flow chart for bacterial vaccine.

2. General method for Vaccine production 1.The production and cultivation 2. Harvesting blending Filling and drying of bacteria culture after incubation k/a harvest . process for vaccine is dispensed Provide nutrition through suitable nutrition overall mixing . In sterile Ampoule Media and choice of media. 1. Killing 2. Separation Fractionation Detoxification and bottles . heat & process by which In process active Liquid media are preferred over solid media formalin cells are separated . Conversion of toxin constituents are diluted. After dispensing For production purpose are to toxoid. they are freezed used. Centrifugation or precipitation Addition of preservative dry before Can be used in large fermenter vessels Phenol formalin is used for and adjuvants. Selling . Easily manipulated as compared to solid vaccine prepared from cells fluid Corynebacterium media Vibrio discarded, cells are resuspended diptheriae . Addition of toxoid suspension cholera in saline . In desired quantity. The production of a bacterial vaccine begins with separate a content and grown vaccines are prepared from the fluid blending without in to small flasks. (Production media) constituent, cell are discarded . Adjuvant k/a plain vaccine The organisms in the preproduction media are process by which components used to inoculate the production media,either are extracted from cells and blending with adjuvant k/a In small container or in fermenter. Medium . Adsorbed vaccine

3. 5. Quality control provide assurance of both efficacy and the safety 2.Final product control 1.In process Control 3. Test for general application products are tested for 1. Identity test 2. Potency Assay : 3. Safety testing : the presence of free toxin, ensures that material Use in humans to Diphtheria and tetanus 1. sterility :- Preferred method is due to inadequate in ampoule corresponds measure protective toxoid requires membrane filtration. detoxification with formalin. to ampoule label. Efficacy of vaccine additional test which 2. Free from abnormal toxicity:- Ex. Diphtheria reveals that they have group of mice and guinea pig And tetanus vaccine. Bacterial Vaccines checked Diphtheria vaccine test detoxified toxins. Tested with human dose all are by precipitation and animal is injected with must be survived for 7 days. In process control provides agglutination reaction vaccine with small Killed viral vaccines have 3. Free formalin:-Inactivation of for tests on the undiluted amount of diptheria potential hazardous due toxin with formalin leads to concentrates and thus increases toxoid. Animal with to incomplete inactivation presence of formalin(product) the sensitivity of the antitoxin neutralize the of them and their residues. Conc. Mus not exceed 0.02%. method at least 10 fold. Toxin and shows no 4.Phenol concentration:-Phenol is reaction other produce Attenuated viral vaccines used to preserve vaccine its In this method infectivity is destroyed erythema on site. Have potential hazardous conc must not exceed from in the inactivation process are associated with reversion 0.25%w/v to 0.5%w/v. 3+3 dose quantal assay of virus during production Monkey kidney cell cultures tested for is used to estimate whooping simian herpes B, virus, simian virus 40 , cough and cholera vaccine . 3 test doses and 3 standard doses are given and check potency by comparison .

4. THANK you….