STANDARD LEVEL 1 PROCEDURE

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CLEANING

LEVEL 1 STANDARD Clean tools are essential to help eliminate or reduce the possibility of product sticking and picking to the punch face. Clean tools are also crucial to aid in increasing the life of the punches, tablet press and reducing the possibility of product cross-contamination. Choosing appropriate cleaning equipment is critical for an effective tool maintenance program. Many times, equipment selection is limited to an authorized budget. Unfortunately, most companies will save more in the long run versus noticeable immediate savings. Due to budgetary constraints, things to consider when making your selection are: 1.) the quantity of tool sets required to be cleaned, 2.) footprint of dedicated maintenance program space available, and 3.) proper training. It is also beneficial to calculate growth for future budget and needs. Natoli Engineering will help and assist to establish SOP s and proper protocols for all levels. Before making your final equipment choices, consult with a Natoli representative to discuss the benefits and features of each level. ABOUT LEVEL 1 STANDARD CLEANING Properly cleaned tooling can reduce press downtime and premature tooling failure while keeping tooling in great condition. The Level One Standard Cleaning Kit includes everything you need to keep tooling production ready. PROCEDURE Remove tooling from tablet press and place in the Acetal Tool Wash Basin (E1) and clean. Use Lint-Free Wiping Cloths (B1) with Pharma Kleen One-Step Rust/Corrosion Preventative Cleaner & Lubricant (D1) or other rust-preventative cleaning agent to reduce contamination issues. Transfer punches into the Stainless Steel Punch Basket (G1, H1) and Stainless Steel Die Basket (I1, J1) and transport to the cleaning area. Examine punch cups closely for leftover debris. If necessary, use 6" Embossing Picks (F1) or Soft- Tip Nylon Brush (M1) to remove difficult, embedded formulation, then place on Punch Holding Strip (C1). If returning punches to production, sanitize tooling after cleaning with 99% isopropyl alcohol. If storing tooling, apply H-1 Food-Grade Tooling Storage Protectant (N1) and store tooling at a Relative Humidity Condition (RHc) in Natoli s Tooling Storage Boxes (O1). Always clean and dry tooling immediately to reduce the possibility of discoloration and corrosion. For optimum cleaning results, perform these steps after each press run. 2

N1 A1 L1 G1, H1 A D1 B1 I1, J1 E1 K1 Red Black C1 M1 F1 O1 CLEANING LEVEL 1 KIT (MA 8030) A1. MA 3000 Spray Bottle: 16oz, 2/pack 1 B1. MA 6018 Lint-Free Wiping Cloths: 42 x 38 cm. 140/pack 1 C1. MA 6025 Interlocking Punch Holding Strip* 8 D1. MA 6032 Pharma Kleen One-Step Rust/Corrosion Preventative Cleaner: 1gal 1 E1. MA 6250 Acetal Tool Wash Basin 241/4" x 10" x 2" 1 F1. MA 7515 Embossing Picks: 6" linen phenolic, 6/pack 1 G1. MA 7533 Stainless Steel Punch Basket: "B" (holds 55 punches)* 1 H1. MA 7535 Stainless Steel Punch Basket: "D" (holds 55 punches)* 1 (not shown) I1. MA 7534 Stainless Steel Die Basket: "B" (holds 50 dies) 1 J1. MA 7536 Stainless Steel Die Basket: "D" (holds 55 dies) (not shown) 1 K1. MA 9000 Heat Gun: 130F to 930F 1 L1. MA 9010 Protectant Facemask 1 M1. SU 0500 Soft-Tip Nylon Brush 6 N1. SU 2545 H-1 Food Grade Tooling Storage Protectant: 1gal 1 O1. MA 5178 Tooling Storage Box with Lid and Insert 2 Items may vary from listed specification to ensure finest quality and performance. *Tooling not included. Available in Cream, Red or Black with "B" or "D" Insert. 3

LEVEL 2 ADVANCED ABOUT LEVEL 2 ADVANCED CLEANING The Tabletop Ultrasonic Cleaner(A2) featured in the Level Two Advanced Cleaning Kit features high-frequency pulsations to remove oils, grease, oxides and particulate matter. The ultrasonic cleaning unit works in conjunction with the Stainless Steel Punch Basket (G1, H1) and (I1, J1). The wire basket is available in both B and D tool configurations. It is critical that the tools are dried properly to eliminate any surface corrosion or discoloration. Level Two Advanced Cleaning Kit is equipped with a hand dryer to properly and safely dry your tools. The Tabletop Ultrasonic Cleaning Unit (A2) and Alkaline Wash Solution (B2) featured in the Level Two Advanced Cleaning Kit is a cost-effective way to clean tooling. The Stainless Steel Trays (C2, D2) make transportation easy by holding both punches and dies. After loading with tooling from the tablet press, place a tray directly into the Tabletop Ultrasonic Cleaner and begin the wash cycle! PROCEDURE Remove tooling from tablet press, and use Lint- Free Wiping Cloths (B1) to wipe product debris and oils from punches and dies. Place punches in the Stainless Steel Tray with- Handles (C2, D2) and transport to the cleaning area. Fill Tabletop Ultrasonic Cleaning Unit (A2) with a mix of purified or deionized water and Natoli Alkaline Wash Solution (B2) or other approved alkaline wash solution. Submerge punches and dies into the Tabletop Ultrasonic Cleaner (A2), and set for recommended time and temperature. If necessary, use the 6" Embossing Picks (F1) or Soft-Tip Nylon Brush (M1) to remove embedded formulation. Rewash if material remained. Dry punches and dies immediately with the Variable Temperature Heat Gun (K1), while still in tray. If returning to production, sanitize with 99% isopropyl alcohol. If storing tooling, apply H-1 Tooling Storage Protectant (N1) and keep in a low-humidity environment under 50% RHc to prevent corrosion and discoloration. For best storage, keep in Natoli s Tooling Storage Boxes (O1). 4

B2 A2 Features: 7-gallon (26.1 L) tank capacity Holds up to 72 punches / 38 dies All models are ETL / CSA approved Precisely controls time, heat, and power Tank dimensions 19½ x 11¾ x 8" C2, D2 E2 CLEANING LEVEL 2 KIT (MA 8031) A2. MA 6100 Tabletop Ultrasonic Cleaner w/ Wire Basket 1 B2. MA 6026 Natoli Alkaline Wash Solution: 1gal 1 C2. MA 5082 Stainless Steel Tray w/ Handles: "B" tooling sets* 1 D2. MA 5084 Stainless Steel Tray w/ Handles: "D" tooling sets* 1 E2. MA 5100 Replacement Tips for Stainless Steel Tray 12 F2. MA 6235 Punch Holding Tray: "B" 26½ x 7 x ¾ (not shown) 1 G2. MA 6236 Punch Holding Tray: "D" 26½ x 7 x ¾ (not shown) 1 A1. MA 3000 Spray Bottle: 16oz, 2/pack 1 B1. MA 6018 Lint-Free Wiping Cloths: 42 x 38cm 140/pack 1 C1. MA 6032 Pharma Kleen One-Step Rust/Corrosion Preventative Cleaner: 1gal 1 E1. MA 6250 Acetal Tool Wash Basin: 24¼ x 10 x 2 1 F1. MA 7515 Embossing Picks: 6 linen phenolic, 6/pack 1 K1. MA 9000 Heat Gun: 130 F to 930 F 1 L1. MA 9010 Protectant Facemask 1 M1. SU 0500 Soft-Tip Nylon Brush 6 N1. SU 2545 H-1 Food Grade Tooling Storage Protectant: 1gal 1 O1. MA 5178 Tooling Storage Box with Lid and Insert 2 Items may vary from listed specification to ensure finest quality and performance. *Tooling not included. Available in Cream, Red or Black with "B" or "D" Insert 5

LEVEL 3 ULTIMATE ABOUT LEVEL 3 ULTIMATE CLEANING Upgrade cleaning efficiency with the 3-Piece Ultrasonic Cleaning System Units. The modular units are designed to work in conjunction with each other. However, they can be purchased or used individually to customize your cleaning requirements. The modular drying unit comes equipped with an air wand that can be used to remove excessive water. If necessary, use the 6" Embossing Picks (F1) or Soft-Tip Nylon Brush (M1) are provided to remove difficult or embedded formulations or repeat cleaning cycle. After cleaning, if the tools are to be put in storage or inventory, it is recommended to store tools with Natoli H-1 Tooling Storage Protectant (N1). Store tooling in low humidity environments to eliminate surface discoloration and corrosion. The floor model, three-piece Stainless Steel Ultrasonic Cleaning System (A, B, C) allows for quick and easy transfer of tooling from the wash to rinse to drying tanks with little effort a great time and labor saver! The entire cleaning cycle can be completed in about 20 minutes and provides a controlled and consistent clean that can validate a cleaning process. Use the Natoli Alkaline Wash Solution (B2) and Chem-Crest 77G Rinse Additive and Corrosion Inhibitor (D3) with the applicable units. Use of these products will provide the highest quality clean for your tablet compression tooling. PROCEDURE Remove punches and dies from tablet press and transport to the cleaning area in the Stainless Steel Tray with Handles (C2, D2). Next, fill the 3-Piece Ultrasonic Cleaning System's Wash Unit (A3) with a mix of purified or deionized water and Natoli Alkaline Wash Solution (B2). Also, fill the Rinse Unit (B3) with a mix of Chem-Crest 77G Rinse Additive and Corrosion Inhibitor (D3) and purified or deionized water. Load punches and dies into the wash unit and run wash cycle (10 minutes). After completion, move tooling to the rinse unit and run rinse cycle (2-3 minutes). Place punches and dies into the Dryer Unit (C3) and run dry cycle (5-6 minutes. If necessary, use 6" Embossing Picks (F1) or Soft-Tip Nylon Brush (M1) to remove difficult, embedded formulation. Repeat cleaning cycle if necessary. If returning to production, sanitize with 99% isopropyl alcohol. If storing tooling, apply H-1 Tooling Storage Protectant (N1) and keep in a low-humidity environment under 50% RHc to prevent corrosion and discoloration. For best storage, keep in Natoli s Tooling Storage Boxes (O1). 6

C3 B3 A3 D3 Ball Fill Valve Emergency Power Shutoff Main Power Switch Compressed Air Wand Drain Connection CLEANING LEVEL 3 KIT (MA 8033) A3. MA 7643 Stainless Steel Ultrasonic Wash Unit 1 B3. MA 7641 Stainless Steel Ultrasonic Rinse Unit 1 C3. MA 7642 Stainless Steel Ultrasonic Drying Unit 1 D3. MA 6036 Chem-Crest 77G Rinse Additive and Corrosion Inhibitor: 1gal 1 B2. MA 6026 Natoli Alkaline Wash Solution: 1gal 1 C2. MA 5082 Stainless Steel Tray with Handles: "B" tooling sets 2 D2. MA 5084 Stainless Steel Tray with Handles: "D" tooling sets 2 E2. MA 5100 Replacement Tips for Stainless Steel Tray 24 N1. SU 2545 H-1 Food Grade Tooling Storage Protectant: 1gal 1 O1. MA 5178 Tooling Storage Box with Lid and Insert 2 Items may vary from listed specification to ensure finest quality and performance. *Tooling not included. Available in Cream, Red or Black with "B" or "D" Insert 7

Ask Your Natoli Sales Representative About Our Other Tooling Maintenance Brochures INSPECTION POLISHING 8 2017 Natoli Engineering Co., Inc. Form 1001-NDA, 12/17