Standard Operating Procedure for Handling and Storage of FFS Film Rolls

1) Purpose

The purpose of this SOP is to establish guidelines for the proper handling, storage, and use of Form-Fill-Seal (FFS) film rolls in pharmaceutical manufacturing to ensure product quality and integrity.

2) Scope

This SOP applies to all personnel involved in the handling and storage of FFS film rolls within the facility.

3) Responsibilities

3.1 Warehouse Personnel
– Receive, inspect, and store FFS film rolls according to specified conditions.
– Maintain inventory records and ensure proper rotation of stock.
3.2 Production Operators
– Handle FFS film rolls during machine setup and production runs.
– Ensure proper alignment and tension of film rolls to prevent operational issues.
3.3 Quality Assurance (QA) Personnel
– Conduct periodic inspections of stored film rolls to verify integrity and suitability for use.
– Investigate and document any deviations related to film roll handling or storage.

4) Procedure

4.1 Receipt and Inspection
4.1.1 Receive FFS film rolls from approved suppliers and verify delivery against purchase orders.
4.1.2 Inspect film rolls for damage, defects, or discrepancies in specifications.
4.2 Storage Conditions
4.2.1 Store FFS film rolls in a controlled environment with specified temperature and humidity conditions.
4.2.2 Ensure film rolls are protected from light, moisture, and contaminants that could affect quality.
4.3 Handling and Use
4.3.1 Handle film rolls with care to avoid punctures, tears, or other damage.
4.3.2 Use appropriate handling equipment and techniques during loading, threading, and positioning on FFS machines.
4.4 Inventory Management
4.4.1 Maintain accurate records of FFS film roll inventory, including lot numbers, quantities, and expiration dates.
4.4.2 Rotate stock based on first-in, first-out (FIFO) principles to minimize waste and ensure freshness.
4.5 Quality Control Checks
4.5.1 Perform visual inspections of film rolls before and during use to detect defects or abnormalities.
4.5.2 Quarantine and investigate any film rolls suspected of non-conformance to specifications.

5) Abbreviations, if any

– FFS: Form-Fill-Seal
– QA: Quality Assurance
– FIFO: First-In, First-Out

6) Documents, if any

– Film Roll Inspection Records
– Inventory Management Logs
– Non-Conformance Reports

7) Reference, if any

– ISO 15378:2017 Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO 9001:2015, with Reference to Good Manufacturing Practice (GMP)

8) SOP Version

Version 1.0