Standard Operating procedure for Tub Handling of Pre-filled syringes of filling machine
1.0 Purpose: To explain how to handle pre-filled syringe tubs with a filling machine.
2.0 Applicable: This Standard Operating Procedure applies to handling pre-filled syringe tubs at the Vaccine Formulation Plant.
3.0 Responsibility: 3.1 Line coordinators who are trained will carry out the processes.
3.2 Officers/Sr. officers will supervise the procedure.
3.3 Head of Production or their designee is responsible for implementing this SOP.
3.4 The head of Quality Assurance ensures SOP compliance.
4.0 Safety considerations:
4.1 Handle tubs with care during transfers.
4.2 Check tubs received from the warehouse for damage.
4.3 Disinfect tubs taken from PP boxes with filtered IPA 70% v/v and transferred through the dynamic pass box into respective areas.
4.4 Always open the tub under a Laminar Air Flow (LAF) unit.
5.0 Procedure:
5.1 Receive QC-approved boxes of pre-filled syringes from the warehouse and store them in the approved primary packing material store in the production area before use in the filling.
5.2 Transfer boxes on a cleaned SS trolley (with appropriate labeling) through the wide corridor as needed.
5.3 Open boxes with a box cutter.
5.4 Disinfect packed tubs by spraying filtered 70% IPA and transfer through DPB in the Material Air Lock.
5.5 Tear off the approved label from the empty box and transfer it to the waste collection area through the Static pass box for destruction.
5.6 Transfer tubs to a clean SS Trolley from DPB to the Loading Area.
5.7 Disinfect packed tubs by spraying filtered 70% IPA and transfer through DPB from the Loading Area to the Buffer Zone and record tub transfer details in Annexure 1.
5.8 Remove tubs from the poly bag in and load them into the Mobile transfer trolley.
5.9 Transfer the Mobile LAF trolley to the PFS filling room.
5.10 Transfer each tub directly from the mobile trolley to the tub loading area of the PFS filling machine before filling.
Related SOP: SOP on Cleaning, operation, and calibration of balance
5.11 Remove the Tyvek cover of the tub only under Filling LAF by lifting and dragging the cover diagonally to the corner of the tub with sterile forceps (SS 316).
5.12 Remove the leaflet from the tub using sterile forceps and keep it under LAF. Then load the tub as per the given SOP.
5.13 After filling, cover each tub again with a leaflet.
5.14 Place filled and covered tubs into the poly bag in and send them to through DPB on a cleaned SS trolley.
5.15 Transfer-filled tubs in lots of not more than 25 tubs.
5.16 Seal-filled pre-filled syringe tubs with tape.
5.17 Transfer sealed tubs with poly bags through DPB.
5.18 Place filled tubs with poly bags in cleaned and labeled crates and transfer them to the warehouse through the Dynamic pass box on a cleaned SS trolley.
5.19 After transferring the tubs, provide a Semi Packed Transfer Note to the warehouse.
5.20 Store the tubs in the cold storage room of the warehouse until the packing process begins.
5.21 In case of online packing, transfer filled tubs to the production Cold room through the corridor.
5.22 Before starting packing, fill in the semi-packed material request as per the given SOP.
5.23 Receive tubs from the warehouse through the Dynamic pass box on a cleaned SS trolley and transfer them to the cold room of the production area.
5.24 Take tubs with pre-filled syringes to the PFS visual inspection room where automatic inspection of PFS is carried out.
5.25 After visual inspection, send pre-filled syringes for further online packing.
5.26 Send empty tubs from the visual inspection area to the waste collection area through the Static pass box for destruction.
Related SOP: SOP on Movement of Materials from one stage to another
6.0 References:
Not Applicable.
7.0 Annexure:
Annexure No. 1: Log book for Tub Transfer (1 page)
8.0 Distribution:
Master Copy: Archived with Quality Assurance Department
Controlled Copy: Production Department
Subsequent controlled copies: Department(s) making requisition
9.0 Abbreviations:
SOP: Standard Operating Procedure
Rev.: Revision
SS: Stainless Steel
QA: Quality Assurance
IPA: Iso Propyl Alcohol
PR: Production
ID No.: Identification number
LAF: Laminar Air Flow
DPB: Dynamic Pass Box
SPB: Static Pass Box
v/v: volume by volume
PFS: Pre-Filled Syringe
%: Percent
PP: Polypropylene
