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• PTS • T R A I N I N G S E R V I C E

Toxic Material Handling

ISPE – PDA Conference Australia • am 18.09.2012 Melbourne 19th September 2019

Koji Ushioda SKAN [email protected] High Potent Material Process Overview

Non aseptic Bulk Aseptic Bulk

Scaling and dispensing Scaling and dispensing

Formulation Formulation

Sterilization

Aseptic Filling Aseptic Filling

Sterility testing Sterility testing High Potent Material Process Overview

Non aseptic Bulk Aseptic Bulk

Scaling and dispensing Scaling and dispensing

Formulation Formulation Aseptic Containment Containment Sterilization

Aseptic Filling Aseptic Filling Aseptic

Sterility testing Sterility testing High Potent Material Process Overview

Non aseptic Bulk Aseptic Bulk

Scaling and dispensing Scaling and dispensing

Formulation Formulation Aseptic Containment Containment Sterilization

Aseptic Filling Aseptic Filling Aseptic

Sterility testing Sterility testing High Potent Material Process Overview

Non aseptic Bulk Aseptic Bulk

Material in Material in

Scaling and dispensing Scaling and dispensing

Dilution source Dilution source

Formulation Formulation Container (Syringe and etc.) (Syringe vial and etc.)

Sterilization

Aseptic Filling Aseptic Filling Rubber Rubber stopper

Environment monitoring etc Environment monitoring etc Sterility testing Sterility testing High Potent Material Process Overview

Non aseptic Bulk Aseptic Bulk

Material in Material in

Scaling and dispensing Scaling and dispensing

Dilution source Dilution source

Formulation Formulation Container Container (Syringe vial and etc.) (Syringe vial and etc.)

Sterilization

Aseptic Filling Aseptic Filling Rubber stopper Rubber stopper

Environment monitoring etc Environment monitoring etc Sterility testing Sterility testing High Potent Material Process Overview

Non aseptic Bulk Aseptic Bulk

Material in Material in

Scaling and dispensing Scaling and dispensing

Dilution source Dilution source

Formulation Formulation Container Container (Syringe vial and etc.) (Syringe vial and etc.) Aseptic Containment

Containment Sterilization

Aseptic Filling Aseptic Filling Rubber stopper Rubber stopper Aseptic

Environment monitoring etc Environment monitoring etc Sterility testing Sterility testing Categorization of toxicity Toxic Process Containment Isolator

Non Aseptic and Toxic Bulk

Scaling and dispensing

Formulation

Filter (Containment) FiPa / FIBO Aseptic Filling

Sterility testing

RTP Split Valve Liner connection Material in/out etc. Bulk in/out etc. Material in/out etc. Aseptic Formulation Aseptic transfer

Aseptic Bulk

Scaling and dispensing

Connecting Isolator Mobile unit from process to process Formulation

Aseptic Filling

Sterility testing

: Aseptic transfer Rapid or Super rapid deco. Air lock (SARA) SART connector RTP Bulk Material etc. Environment monitoring / waste etc. WFI or any other sterile liquid Fill Finish

Aseptic Bulk

Scaling and dispensing

Formulation E-beam Sterilization Solution

Aseptic Filling

Sterility testing

Dry Heat Tunnel Bulk material (Syringe / Vial / Ampule / Cartridge) Fill Finish

Aseptic Bulk

Scaling and dispensing

Formulation

SARA Aseptic Filling Tools / Waste etc.

Sterility testing

Process system / Beta system RTP RTP Rubber stopper supply Product Transfer Tool/Waste etc. Sterility Test

Aseptic Bulk

Scaling and dispensing

Formulation

SARA Aseptic Filling Tools/Waste etc.

Sterility testing

RTP Tool/Waste etc. ADC Process Storage final Product, Inspection, Packaging

Workshop with a Customer Aseptic ADC to design an appropriate solution

Storage final Product Isolator for Inspection

Inspection

Packaging

Isolator for Packaging ADC Process Product and Format Change

Aseptic ADC

Off Line Cleaning Isolator for Cleaning Isolator Isolator

Critical area Leak Qualification

Pressure Decontamination Monitoring

Filter Process equipment Operator Training

AHU Transfer / Connection Maintenance

Room Cleaning Others Decision process of isolator leak rate

Guideline (Internal and external)

Outline Isolator Analysis (GMP) ISO Containment Leak test method

Isolator system risk analysis Risk analysis SIS700

Swiss accident insurance Limitation for work station H2O2 gas concentration measurement H2O2 sensor calibration method

Distribution of H2O2 gas

Use of H2O2 sensor Calculation of isolator leak Isolator

Critical area Leak Qualification

Pressure Decontamination Monitoring

Filter Process equipment Operator Training

AHU Transfer / Connection Maintenance

Room Cleaning Others Pressure

Differential pressure Only containment

Isolator

-

Always negative pressure 21 Pressure

Vial line (aseptic only)

+ + + +

Buffer Fill Stoppering Capping

Air Flow (by design, depending on phase)

Together always one step ahead www.skan.ch Isolator

Critical area Leak Qualification

Pressure Decontamination Monitoring

Filter Process equipment Operator Training

AHU Transfer / Connection Maintenance

Room Cleaning Others Filter

•BIBO Filter Filter

•Issues of BIBO solution

1. Replace the filter in interstitial area (exposure risk)

2. Space required to replace the filter

3. Washing from dedicated exhaust area to BIBO

4. Cleaning validation for the above area

5. High consumption of washing water

1. Containment solution within isolator (No toxic substances outside isolator)

2. Space for filter replacement can be reduced.

3. Dedicated exhaust area should be out of scope for washing.

4. Cleaning validation can be limited inside isolator.

5. Minimize waste water. •FIBO Filter Filter

FIPA Filter

FIPA filters

Isolator

Critical area Leak Qualification

Pressure Decontamination Monitoring

Filter Process equipment Operator Training

AHU Transfer / Connection Maintenance

Room Cleaning Others Filtration Sterilization for Bulk and Tub Transfer

Split Valve

Information by Charge point / Buck Transfer

RTP

Information by CRL Transfer

Liquid Transport (AT port)

Information by Aseptic Technology Transfer

Liner Transfer

Pass Summary

Containment solution Select proper containment solution

Aseptic solution Always important to stand both containment and aseptic

Connection Select proper connection based on the process and material handling • PTS • T R A I N I N G S E R V I C E

Thank you

• am 18.09.2012

•Together always one step ahead www.skan.ch