Seed lot system:
A system according to which successive batches of product (e.g. CBPP vaccine) are prepared using the same master seed lot.
Master seed lot:
A collection of aliquots of live attenuated M. mycoides subsp. mycoides (SC bovine biotype) - strain T1SR (49th broth culture passage) or T1/44 (44th egg passage) which has been cultured, distributed into containers and lyophilised in a single operation and stored in such manner as to ensure uniformity and stability. It shall be assigned a specific code for identification purposes. It shall have been shown that upon parenteral administration to cattle the Master seed lot is safe and able to confer immunity/protection of at least one year's duration.
Seed lot (Working seed lot):
A quantity of live attenuated M. mycoides subsp. mycoides (SC, bovine biotype) possessing specifically defined characteristics and treated in a uniform and single operation. Such a seed lot is used to produce a large number of successive baatches of vaccine. It is freeze dried and stored at -20°C.
A seed lot must be shown to be safe for cattle when administered under natural conditions and must be capable of conferring an immunity that lasts for at least one year.
Inoculum:
A subculture from the working seed lot that is used to seed broth culture medium intended for the preparation of bulk vaccine suspension/culture.
Bulk suspension:
Mycoplasma harvest from the same culture medium, following inoculation with the same inoculum, incubated under the same conditions and for similar duration of incubation period. It may be in a single container or it may be a pool from more than one similar containers.
Batch:
All the sealed final containers derived from the same homogeneous bulk culture suspension. Each batch shall be identified by a code. It shall be labelled accurately and informatively.
Filling/Final lot:
A collection of sealed final containers, representing part or whole of a vaccine batch, which have been exposed to the same risks of contamination during mixing with stabilizer, filling, freeze drying and sealing. All the material comprising a final lot shall have been dispensed during a single operation and lyophilised and sealed simultaneously.
