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Aseptic Processing Manipulation

Interventions are aseptic processing manipulation necessary for batch processing aseptically.
Interventions are categoriesed-
1.Based on requirements
1.1. Corrective
A) Open Door
B) Closed Door
1.2. Inherent
A) Open Door
B) Closed Door
2.Based on impact
2.1. Critical
2.2. Major
2.2. Minor

Inherent interventions (Routine interventions)
Inherent (routine) close door:
Example: Addition of rubber stoppers

Inherent (routine) open door:
Example: Initial filling parts assembly etc.

Corrective interventions (Non routine interventions)
Corrective (non routine) close door:
Example: Clearing of vial jam from infeed turn table, clearing of seal jam in chute by forceps,etc.

Corrective (non routine) open door:
Example: Glove port glove fixation for cRAB, sealing roller head / sealing die adjustment, etc.

Critical intervention:
Directly pose risk of contamination to the product or zone of sterilized product/container closure exposure.

Major intervention:
May pose probability of chance contamination to the product.

Minor intervention:
Unlikely to pose probability of chance contamination to the product.

Inherent + Open door + Critical= Filling machine assembly
Inherent + Open door + Major=
Inherent + Open door + Minor=

Inherent + Close door + Critical=
Inherent + Close door + Major= Settle plate change in cRAB
Inherent + Close door + Minor= Addition of seals

Corrective + Open door + Critical= Detachment of glove from glove port
Corrective + Open door + Major=
Corrective + Open door + Minor=

Corrective + Close door + Critical=
Corrective + Close door + Major= Filter Air Removal
Corrective + Close door + Minor= Removal of rejected vial from sealing rejection tray
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