1.0 Purpose
1.1 To describe procedure to be followed for proper cleaning and storage of Dies and Punches and to maintain Dies and Punches in proper and in efficient working order in compliance with product quality.
2.0
Scope
2.1 This Sop is applicable for all Dies and
Punches of tablet manufacturing area of "NAME" Pharmaceuticals Ltd.
3.0
Responsibility
3.1
Concerned Operator and
Supervisor to follow the procedure correctly.
3.2
Production Officer and Quality
Assurance Officer should ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 Not Appreciable
5.0 Materials and Equipment
5.1 IPA (Isopropyl Alcohol 100%)
5.2 Sodium Lauryl Sulphate Solution (1%)
5.3 White Soft Paraffin
5.4 Liquid Paraffin
5.5 SS bucket
5.6 Dry & clean cloth
6.0 Precaution / Health and Safety Considerations
6.1 IPA (Isopropyl Alcohol) is highly flammable, so protect IPA from risk of fire.
6.2 Wear safety mask during handling of IPA.
6.3 Ensure that during cleaning of Dies and Punches, the punch tip should not come in contact with any hard surface.
7.0 Procedure
7.1 Cleaning
7.1.1 Remove the dies and punches from the machine after completion of the work.
7.1.2 Remove adhered dust and sticky materials by a clean and dry cloth.
7.1.3 Handover the dies and punches to the trained operator responsible for die punch cleaning.
7.1.4 Dip the dies and punches to 1% Sodium Lauryl Sulphate solution into SS bowl one by one and wipe with wet cloth which is soaked in 1% Sodium Lauryl Sulphate solution to remove adhered sticky materials from the dies and punches.
7.1.5 (Preparation of 1% Sodium Laurel Sulphate: Mix 10 g Sodium Lauryl Sulphate with 1.0 Liter water). Use the solution as per requirement.
7.1.6 Take 8-10 Liter fresh Purified Water into a SS bowl.
7.1.7 Remove the punches and dies from Sodium Lauryl Sulphate solution one by one and immerse those into fresh water.
7.1.8 Clean the surface of the dies and punches until to remove Sodium Lauryl Sulphate residue.
7.1.9 Remove the dies and punches from water one by one and then wipe those with a clean and dry cloth.
7.1.10 Wipe with a clean cloth moistened with IPA (Isopropyl Alcohol 100 %).
7.2 Storage
7.2.1 Spread Paraffin over the surface of dies and punches. (Paraffin- White Soft Paraffin and Liquid Paraffin in a ratio of 50%).
7.2.2 After spreading, arrange dies and punches in a tray of particular cabinet drawer and inform the
Supervisor to check the proper storage.
7.2.3 Put name and signature in the die punch maintenance register book.
8.0
Reference
Document
8.1 In-house
9.0
Annexure
9.1 Not Appreciable
10.0 Revision History
Revision No. | Brief reason for the revision | Effective Date | Remarks |
01 | New |
|
|
11.0 Training
11.1 Head of Production or his nominee give the training of production operator and worker.
