Learn About the Procedure for Thawing of Solution and Active Raw Material stored at or below -20 degrees C.
1.0 Purpose: To lay down the procedure for thawing of active raw material & solutions that are stored at or below -20 degrees C.
2.0 Applicable to: This Standard Operating Procedure is applicable for thawing of active raw material & solutions stored at or below -20 °C before their use in a vaccine batch at the production floor in Pharmaceuticals.
3.0 Responsibility:
3.1 Sr.officers / officers shall execute this SOP with the help of trained line coordinators.
3.2 Sr. Manager /Manager shall supervise the whole process.
3.3 Head QA shall be responsible for the authorization of this SOP.
4.0 Safety considerations:
4.1 Wear proper gloves While handling bottles stored at -20 °C.
4.2 Care should be taken while handling material stored at or below -20 °C.
5.0 Equipment:
5.1 Deep freeze -20° C
5.2 Cold room (2-8°C)
5.3 Dynamic pass box
5.4 Static pass box
5.5 Laminar air flow
6.0 Materials and reagents:
6.1 Dry ice packs
6.2 Thermocol box
6.3 Lint-free Mops
6.4 Sterile 70% IPA.
6.5 Cryo gloves
7.0 Preparation of solutions:
Not applicable
8.0 Procedure for Thawing of Solution:
8.1 Receive the material to thaw from stores through a static material pass box in a thermocol box filled with dry ice as per SOP “Transfer & receipt of bulk (active raw material) from warehouse to the production area”.
8.2 The box that receives the material shall be externally cleaned using a sterile 70% IPA with a lint-free mop.
8.3 Wear hand gloves while handling bulk bottles.
8.4 The material to be thawed is transferred into the cold room (Range 2-8 °C) & stored until the solution or active material gets thawed completely.
8.4 Continuously monitor the cold room to ensure the temperature and data are within specified limits.
8.5 The thawing data shall be attached with the respective protocol or BMR for further reference.
9.0 Reporting:
9.1 Record the details of the process in the respective BPR.
10.0 References:
Not applicable.
11.0 Annexure:
Not applicable.
12.0 Abbreviations:
SOP: Standard operating procedure
QA: Quality assurance
HOD: Head of the department
VFP: Vaccine formulation plant
LAF: Laminar air flow
IPA: Isopropyl alcohol
No. : Number
PR: Production
EQP: Equipment
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