E 03 — Aseptic Processing Technology 2008 Case

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E 03 - Aseptic Processing Technology 2008 Case Study: Application of Peristaltic Filling for Flexibility and Accuracy • by • • Ted Kemnitz Automated Machine Technologies, Inc. • • (919) 361 0121 Ted. Kemnitz@AMTLiquid. Filling. com AMT ™

Introduction to Servo Peristaltic Liquid Filling Liquid filling is a major element of Aseptic Processing Technology. This presentation highlights the advantages of using Servo Peristaltic Filling for q üFlexibility q üAccuracy – q üDisposable Technology q üLowest Contamination Risk q ü“Piggyback” System – wide range of products and fill volumes better than 0. 5% with Servo Compensation – best suitable, minimal expense of product contact parts - only peristaltic tubing contacts the product - easy and cost-effective integration into existing infrastructure

Aseptic Liquid Filling – Desired Essentials üConsistent Accuracy and Precision maintained throughout entire q production with minimal set up üReduced risks of contamination with the lowest number of product q contact parts that are easily exchangeable and can be disposable üEliminated dripping after fill via suck-back system q üReduced splashing during fill by optimizing process parameters, such q as number of nozzles, dispensing flow rate, nozzle and tubing sizes, bottom-up filling üFlexibility with easy changeover to different products and fill volumes q

Aseptic Liquid Filling - Desired Essentials üAbility to interface with automatic SPC and PID process for 100% q weight feedback üReduced risk of operator errors by utilizing exchangeable sets of 1. fixed tooling in place of manual adjustments üUser-friendly operation based on simplicity and low maintenance 1. üRugged system with long term consistency and reliability resulting in 2. reduced downtime üEasy integration with existing technologies and existing 3. infrastructure for economical viability

Fig. 1. Servo Peristaltic Liquid Filling

Fig. 2. Servo Peristaltic Liquid Filling Machine “Cantilever” type

Fig. 3 Servo Peristaltic Liquid Filling Machine Guards removed

Fig. 4. Servo Peristaltic Liquid Filling Machine Top view

Fig. 1. Servo Peristaltic Liquid Filling

Fig. 5. Servo Peristaltic Liquid Filling Principle

Fig. 6. Servo Peristaltic Pump Flow Characteristic

Servo Peristaltic Compensation - Principle Example: Integrating 0. 340 ml Dispense

Technology Base - 1994 q Incorporated in 1994 as Automated Machine Technologies, Inc. (AMT™), a manufacturer of packaging machines. q Driven by demand for cost effective, high performance Servo motion controllers q In-house Servo technology development, patents obtained Towards the end of XX century Computer Programmable Servo Systems were evolutionary breakthrough for high performance packaging machines.

CCL Industries, Toronto ON • Development of environmentally friendly aerosol system • 330 parts per minute citric acid dispensing • precision of 0. 5% • Wide range of fill volumes, 0. 2 ml up to 12 ml • Easy changeover and easy cleaning Original solution was urgently needed. ______________ While working with the new aerosol system, coincidently, an ideal product for Aseptic Liquid Filling was created.

Ciba Corning Diagnostic, Walpole MA • Pilot production for diagnostics research • High fill precision and easily programmable changeover to many different products and sizes • Easily removable product contact parts for autoclaving • Adjustable diving nozzles with bottom-up control _____________ An answer was given to the demanding Ciba Corning needs with a two-axis servo peristaltic liquid filling machine and with a linear actuator for programmable nozzles.

Organon Technika, Durham NC • Sterile liquid filling, stoppering and screw capping integrated into one system • One system for over a hundred different products • Precise and aseptic liquid dispensing over wide range from 0. 5 m. L to 1 L • Programmable calibration and changeover __________ The flexibility of the Servo peristaltic pump became apparent when it was incorporated into the multifunctional monoblock system.

UDL Laboratories , Largo FL A manufacturer of Unit Dose Liquid Packs • Existing system required frequent and difficult adjustments of all 40 individual pistons • Lack of fill precision • Difficulty in cleaning piston cavities from sugar based product • Dripping nozzles due to low surface tension • Problem meeting FDA regulations • Large project on-hold until a solution could be found _________________ Servo peristaltic dispenser with compensated flow characteristic was the only answer to the complex demand for filling UDL Unit Dose Liquid Packs. Simplicity of the hardware allowed to build the custom machine economically and in a timely manner, saving the multimillion-dollar project. In fiscal year 2005, UDL shipped over 800 million doses and ranked as the number one generic unit dose supplier.

bio. Merieux, Durham NC A manufacturer of Bac. T/ALERT® blood culture bottles • Replacing glass container and 30 mm stopper with new, cost-effective plastic vial with 20 mm stopper for diagnostic blood culture bottles • Filling through stoppers with 12 piercing nozzles in aseptic production • Smaller stoppers require precise positioning of vials under piercing needles • Easy changeover • Increased fill precision • Reduced risk for contamination __________ With multi-axis capabilities, the Servo Peristaltic Pump was successfully integrated with a Servo-driven timing screw to precisely position the bottles under the needles.

bio. Merieux, Durham NC Servo Peristaltic Dispenser - Automatic SPC with 100% pre-fill/post-fill weight feedback

bio. Merieux, Durham NC A manufacturer of Bac. T/ALERT® blood culture bottles Problems on the main production line: • High maintenance • Dripping nozzles • Complicated and time-consuming adjustments • Difficulties to maintain precise fill weights of +/-1% over 16 hours of continuous production cycle q Disposable Technology and high fill precision at production rates over 300 vials per minute demanded ______________ SOLUTION: - “Cantilever” Servo pump for Disposable Technology - Nozzle-to-nozzle equalizing system with feedback - Automatic tubing wear compensation - Increased fill precision was maintained over 16 hour runs, and need for manual calibration was eliminated - Daily maintenance was reduced from hours to only a few minutes - FDA requirements were easily met with disposable product contact parts One year later, on November 26, 2007, bio. Merieux reported a 10% annual growth in the blood culture market.

bio. Merieux - Servo Peristaltic Data bio. Merieux: Servo Peristaltic Machine Model 239

Siemens Medical Solutions, Walpole MA Diagnostic Reagent Facility Expansion • Increased and sustained fill precision throughout prolonged aseptic production • “On the fly” calibration • Monitoring of fill weights with the use of an automatic sampling system for SPC ____________ -- The Servo Peristaltic pump was the answer to - sustained precision and sterility -- The nozzle servo-mechanism was upgraded with - horizontal movements for automatic sampling A robust growth in the immunodiagnostics business is projected.

Siemens Medical Solutions - Servo Peristaltic Data Servo Peristaltic Machine Model 150

Catalent Pharma Solutions, Raleigh, NC • • • Disposable Technology • ____________ Fill Precision +/- 0. 5% Flexibility with easy changeover Volumes 0. 5 ml to 1000 ml Portable machine, easily integrated with Bosh TL system “Cantilever” Servo Peristaltic Pump was configured into a portable machine and designed for Disposable Technology.

Catalent Pharma Solutions - Servo Peristaltic Data Produced: 02/04/08

Catalent Pharma Solutions - Servo Peristaltic Data Produced: 02/13/08

Fig. 7. 20 -Nozzle Servo Peristaltic System

Fig. 8. “Piggyback” – Servo Peristaltic Dispenser incorporated into Filling & Stoppering Monoblock Machine

Fig. 9. Servo Peristaltic 384 -Well Micro. Plate Dispenser From 0. 5 u. L to 0. 5 m. L; CV=1%

Fig. 11. Peristaltic Micro Pump Fig. 10. Servo Peristaltic Micro. Plate

Fig. 11. Disposable Cartridge for Servo Peristaltic Micro. Plate Dispenser

Servo Peristaltic Machine