Basic requirement of Lyophilization

1. Prepared by : Dushyant Prajapati
Requirements for Lyophilization

2. Area :
1. Grade A is proposed for loading of a lyophilizer.
Contamination :
1 . Contamination Control Strategy should be maintained by container closure system.
Validation :
1. Sterilization of lyophilizers and associated equipment should be validated and holding times between sterilization cycles appropriately
challenged during aseptic process simulations (Media Fill).
2. The lyophilizer should be sterilized regularly, based on system design. Resterilization should be performed following maintenance or cleaning.
CCIT:
1. Samples of containers closed by other methods than by fusion (e.g. stoppered vials) should be taken and checked for container closure
integrity (CCI) using validated methods. The frequency of testing should be based on the knowledge and experience of the container closure
system being used. A scientifically valid sampling plan should be utilized. The sample size should be based on information such as supplier
approval, packaging component specifications and process knowledge. Visual inspection alone is not considered as an acceptable integrity test
method.
Media Fill:
The process simulation procedure for lyophilized products should represent the entire aseptic processing chain including filling, transport,
loading, chamber dwell, unloading and sealing under specified, documented and justified conditions representing worst case operating
parameters. duplicate all aspects of the process, except those that may affect the viability or recovery of contaminants.
take into account various aseptic manipulations and interventions known to occur during normal production as well as worst case situations (e.g.
loading of vials)
Other :
1. Sterilized lyophilizers and associated equipment should be protected from contamination after sterilization.
2. Lyophilizers that are manually loaded or unloaded should be sterilized before each load. For lyophilizers loaded by automated closed systems
or located within systems that exclude operator intervention, the frequency of sterilization should be justified and documented as part of the CCS.

3. Thank You