Tooling Control and Cleaning

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1.0 Purpose 
 
 The purpose of this procedure is to define the cleaning and control of tooling.
 
 2.0 Scope 
 
 This procedure applies to all tooling used in production at Ion Nutritional Labs.
 
 3.0 Responsibility 
 
 It is the responsibility of Production personnel to follow this procedure.
 aa 
 
 It is the responsibility of the Tooling Attendant to follow this procedure.
3.2 It is the responsibility of Production & Maintenance Management to implement this

3.3 procedure and to ensure that the procedure is being followed.

 It is the responsibility of Production and/or Maintenance & Engineering to keep this
3.4 procedure aligned with current practices.

 4.0 Definitions 
 
 4.1 IPA — 99% Isopropyl Alcohol 
 
 4.2 R&D — Research and Development 
 
 4.3 Tooling — Punches and Dies 
 
 4.4 PQV — Process Quality Verification 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 Tooling Control and Cleaning B-201 5 Bape ers 
 
 5.0 References 
 
 5.1 A-106, SOP, Documentation Guidelines for cGMP Records 
 
 D2 C-501, SOP, Document Control 
 
 5.3 C-502, SOP, Record Storage, Retention, and Destruction 
 
 5.4 B-201-F1, Form, Tooling Usage Log 
 
 6.0 Procedure 
 
 6.1 Tooling Logging 
 
 6.1.1 Once the operations team determines that tooling is needed for a machine, they
 will report to the tooling cage and ask that tooling attendant to assist in gathering
 
 the tooling needed to run the machine that is scheduled. 
 
 The operator must bring the production room information and all the batch
6.1.2 information to the cage at this time to log out the tooling.

 Once the tooling attendant has all the information, they will assist the operator to
6.1.3 gather all the tooling needed in the proper sizes and quantities based on the

 information they provide. 
 
 The operations team will locate form B-201-F1 Tooling Usage Log and log all
6.1.4 tooling that is being removed from the tooling cage, ensuring that the tooling is

 being logged correctly and completely. They will need to know what production
 
 room they are setting up, what batch name & number is running, the sizes they
 
 need, & the quantities needed. They will also apply their initials and the date they
 are removing the tooling from the tooling cage. 
 
 Once the log is complete, the tooling attendant will unload the tooling totes and
6.1.5 load the tooling onto a transport cart. While loading the cart, the tooling attendant

 will do a visual inspection of the tooling to ensure they are ready to use. The
 
 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Tooling Control and Cleaning 
 B-201 Page 3 of 5 
 
 tooling attendant will also give the operator any other pieces/parts that may be
 needed with the tooling (ex. dust cups). 
 
 6.1.6 Once the production run is complete, the operator will remove all the tooling from
 the machine and clean any excess powders from the tooling prior to returning it to
 
 the tooling cage. The operator is responsible for logging the tooling back into the
 
 log book and the tooling attendant can begin the cleaning & maintenance needed
 prior to storing into the tooling totes. 
 
 6.2 Tooling Cleaning and Maintenance 
 
 6.2.1 Materials Needed 
 
 62.1.1 IPA 
 
 6.2.1.2 Stainless steel wire brush (wheel type and pencil type)
 
 6.2.1.3. Natoli Barrel-Lube H-1/Natoli Food Grade White Mineral Oil H-1 (or
 equivalent) 
 
 6.2.1.4 Natoli Synthetic Food Grade Grease H-1 (or equivalent)
 
 6.2.1.5 Cotton wheel for polishing 
 
 6.2.1.6 Gloves 
 
 6.2.1.7 Safety Glasses 
 
 zZ }i - @ 
 : Always wear gloves and safety glasses when handling tooling. Punch tips are
 very delicate so treat them accordingly. Avoid punch tip contact with any part of
 another punch, any part of the press, metal tools and equipment, and any part of
 
 the metal storage container. 
 
 6.2.2 Punches and dies removed from a press by the operator, should be wiped with a
 
 clean dry cloth to remove any remaining product /oils. 
 
 
 

[SOP 

 Standard Operating Procedure SOP No | Rev 
 B-201 5 Page 4 of 5 
 Tooling Control and Cleaning 
 
 6.2.3 If any product remains then use a clean dry cloth, soak with 99% IPA, wring
 out the cloth and wipe any remaining product/oils from tooling.
 
 6.2.4 Continue process until tooling is free of any product/oils buildups. Wipe off any
 excess IPA and place on the transport cart. Return the tooling to the tooling
 
 attendant and check in anything being return into the log book.
 
 6.3. Tooling polishing & Inspection 
 
 6.3.1 The tooling attendant will repeat the same process as above, until the punches
 
 are free of material. Use IPA and a cotton cloth to ensure punches and dies are
 thoroughly cleaned. 
 
 6.3.2 Dry with a clean cotton cloth. 
 
 6.3.3 If needed, use the cotton wheel with polishing compound to polish punches to a
 
 mirror shine. 
 
6.3.4 After polishing, inspect the tooling to determine if there is any damage or wear

 that is beyond repair using the proper tooling drawing. Place emphasis on the
 punch tips. Look for bruising outside of the punch tips and check the tips for
 raised burrs and abrasion. 
 
 Check for scoring or binding on the punch barrels and stems. Visually inspect
 6:35 
 the punch bodies for corrosion. 
 
 Inspect the die bores for compression rings in the bores, wear or binding in the
6.3.6 bores, corrosion, and burrs or bruising.

 6.3.7 Notify Maintenance Management if any wear is found. 
 
 6.4 Storage Preparation 
 
 Prior to storage, apply a light coating of Natoli Barrel Lube H-1 or Natoli Food
6.4.1 Grade White Mineral Oil H-1 (or equivalent) to the punch barrels and dies.

 
 

[SOP 

 Standard Operating Procedure SOP No Rev 
 Tooling Control and Cleaning B-201 Page 5 of 5 
 
 6.4.2 Apply a light coating of Natoli Synthetic Food Grade Grease H-1 (or equivalent)
 to the punch heads. 
 
 6.4.3. Measure each punch for wear consistency. Notify Maintenance and Operations
 Management for any inconsistent punch measurement. 
 
 6.4.4 Place tooling in the appropriate tooling tote with the punch tips pointed
 
 downwards. 
 
 6.5 Documentation Requirements 
 
 6:5:1 
 Logbooks will be assigned and distributed as outlined in SOP C-501 Document
 Control. 
 
 A PQV check must be performed for each completed logbook page as outlined
 6'5:2 
 in SOP A-106 Documentation Guidelines for cGMP Records. 
 
 Documents will be maintained following SOP C-502 Record Storage, Retention,
6.5.3 and Destruction.

 7.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 3 | 02/08/17 | Improved clarity and precision of procedure | 17-0145 | C. Fryman |
| 4 | 06/20/19 | Change from 70% IPA to 99% IPA. Clarified procedure. Added in logging information and proper department notifications. | 19-0394 | L. Dush |
| 5 | 09/23/23 | Added form B-201-F1 to log tooling. Updated logo and format. CC- Added documentation requirements. Changed SOP title. | 23-0109 | J. Mireles |

 
 

[SOP 

 Tooling Usage Log 
 Form: B-201-F1 CCR No. CC-23-0109 Revision: 0 
 
 Logbook Number _B-201-F1-B1-030724-050 Area / Equipment Tableting / Tooling Punches (Uppers, Lowers, Dies)
 
 PQV: