Standard Operating Procedure for Syringe Filling and Capping (for SC Injections)

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the filling and capping of syringes intended for Subcutaneous (SC) injections to ensure accurate dosage and maintain product sterility.

2) Scope

This SOP applies to all personnel involved in the filling and capping of syringes for SC injections within the pharmaceutical manufacturing facility. It covers the procedures for equipment setup, filling, capping, and quality control.

3) Responsibilities

– Production Department: Responsible for performing the filling and capping process.
– Quality Control (QC) Department: Monitors the process to ensure compliance with specifications and records data.
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.

4) Procedure

4.1 Equipment Setup
4.1.1 Ensure that the syringe filling and capping equipment is clean, calibrated, and ready for use.
4.1.2 Perform a pre-operation check to verify that all equipment components are functioning properly.
4.2 Preparation
4.2.1 Prepare the bulk drug solution or suspension according to the batch record.
4.2.2 Ensure that the bulk solution meets the required specifications before proceeding with filling.
4.3 Filling Process
4.3.1 Set up the filling machine with the appropriate settings for the specific syringe size and fill volume.
4.3.2 Load the empty syringes into the filling machine hopper.
4.3.3 Begin the filling process, ensuring that each syringe is filled accurately to the specified volume.
4.3.4 Continuously monitor the filling process for any discrepancies or deviations.
4.4 Capping Process
4.4.1 Once filled, transfer the syringes to the capping machine.
4.4.2 Ensure that the caps are properly sterilized before use.
4.4.3 Begin the capping process, ensuring that each syringe is securely capped to maintain sterility.
4.4.4 Monitor the capping process for any issues such as loose or improperly fitted caps.
4.5 Quality Control
4.5.1 Collect a representative sample of filled and capped syringes for quality control testing.
4.5.2 Perform visual inspection, fill volume verification, and sterility testing on the sampled syringes.
4.5.3 Record all quality control results in the batch record.
4.6 Documentation
4.6.1 Document all steps of the filling and capping process in the production logbook or electronic database.
4.6.2 Ensure that all records are reviewed and approved by the QC department.
4.7 Reporting
4.7.1 Prepare a batch production report summarizing the filling and capping process, including any deviations observed.
4.7.2 Submit the report to the QA department for review and approval.
4.8 Corrective Actions
4.8.1 If any quality control tests do not meet specifications, initiate an investigation to identify the root cause.
4.8.2 Implement corrective actions as necessary and document all findings and actions taken.

5) Abbreviations, if any

– SC: Subcutaneous
– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Batch Records
– Production Logbook
– QC Testing Reports

7) Reference, if any

– USP <1> Injections and Implanted Drug Products (Parenterals) – Product Quality Tests
– ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use

8) SOP Version

Version 1.0