E-Beam technology for nested pre Beam technology for nested - - PowerPoint PPT Presentation

E-Beam technology for nested pre Beam technology for nested pre-filled filled syringe tub de syringe tub de-contamination contamination

ISPE CENTRAL CANADA ANNUAL MEETING ISPE CENTRAL CANADA ANNUAL MEETING

MONTREAL MONTREAL MONTREAL MONTREAL

September 30, 2010 September 30, 2010 Jim Spolyar Jim Spolyar

SKAN US, INC SKAN US, INC

WHY USE E WHY USE E-BEAM BEAM

• TODAYS CONFIGURATION OF NESTED SYRINGE

TODAYS CONFIGURATION OF NESTED SYRINGE FILLER WITH E FILLER WITH E-BEAM BEAM

• TRAY DE

TRAY DE-BAGGER; E BAGGER; E-BEAM TUNNEL; AUTO LID PEALER; FILLER/STOPPER WITH AUTO NON BEAM TUNNEL; AUTO LID PEALER; FILLER/STOPPER WITH AUTO NON-

• DESTRUCTIVE CHECK WEIGHING; MOUSEHOLE TRANSITION WITH UNI

DESTRUCTIVE CHECK WEIGHING; MOUSEHOLE TRANSITION WITH UNI-

• DIRECTIONAL

DIRECTIONAL PROTECTION; INTEGRATION TO DOWNSTREAM INSPECTION, LABELLING, PACKAGING, PROTECTION; INTEGRATION TO DOWNSTREAM INSPECTION, LABELLING, PACKAGING, CARTONING, ETC CARTONING, ETC

• SPEED OF FILLING UP TO 6 TUBS PER MINUTE AND INCREASING

SPEED OF FILLING UP TO 6 TUBS PER MINUTE AND INCREASING 2

• REMOVING HUMANS FROM THE PROCESS

REMOVING HUMANS FROM THE PROCESS

WHY USE E

WHY USE E-BEAM WITH NESTED FILLERS BEAM WITH NESTED FILLERS

• 1. VALIDATABLE METHOD TO REACH A 6 LOG REDUCTION OF SPORES ON ALL
• 1. VALIDATABLE METHOD TO REACH A 6 LOG REDUCTION OF SPORES ON ALL

EXTERIOR SURFACES OF THE TRAYS EXTERIOR SURFACES OF THE TRAYS

• 2. REPEATABLE
• 2. REPEATABLE
• 3. ELIMINATES OPERATOR INTERFACE WITH TRAYS
• 3. ELIMINATES OPERATOR INTERFACE WITH TRAYS
• 4. HIGH SPEED INFEED OF TRAYS TO MATCH NEW HIGH SPEED FILLERS
• 4. HIGH SPEED INFEED OF TRAYS TO MATCH NEW HIGH SPEED FILLERS
• 5. ROBUST SYSTEM WITH MEASURABLE KILLING ENERGY SYSTEMS
• 5. ROBUST SYSTEM WITH MEASURABLE KILLING ENERGY SYSTEMS

Alternatives, Advantages, Disadvantages, Risks to E-Beam Sterilization

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Design

• Operates as independent stand alone system with dedicated PLC,

dedicated decontamination system, dedicated pressure control, …)

• Integrated H2O2 decontamination system SIS 700 to allow an

independent decontamination apart from the filling machine isolator

• PLC control with Siemens or Allen Bradley components

E-Beam Decontamination Tunnel

Features

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• Can be used in combination with Isolators, RABS and clean room of

any supplier

• Modular concept to suit AEB e-beam system (light bulb philosophy –

easy, by customer exchangeable emitter system)

• Dimensions: length 2.4m x depth 1.2m x height 3m
• weight:
• floor load: approx. 2 t / m2
• total shielded tunnel: approx. <3.5 tons
• total tunnel including all air handling: approx. <5 tons

Emitter System & Configuration

Triangle configuration

Accommodates 4”

Tub

5

Tub

all Tub surfaces

exposed

• no shadow

distance foil to tub

always < 200mm

Energy is set to achieve 25 kGy under the first Tyvek, but does not penetrate the second Tyvek, to avoid O3 generation inside the syringe

E-Beam Decontamination Beam Decontamination Tunnel Tunnel

decontamination performance decontamination performance

Courtesy of Linac Courtesy of Linac

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FILLER WITH SKAN E-BEAM

www.skan.ch 7

Application of Sterilization with Electron Beam & Isolator Technology for Syringe Tub Transfer

www.skan.ch 8

Tubs in Section1 Emitter Section2 Pealing Filling and Closing Tubs out E-Beam Tunnel Isolator System

Zone Concept & Differential Pressure Cascade Zone Concept & Differential Pressure Cascade

E-Beam Tunnel

Production mode

www.skan.ch 9

0 Pa - 10 Pa > 15 Pa + 25 Pa + 35 Pa + 35 Pa ISO 7/8 ISO 7/8 ISO 7/8/5 ISO 5 ISO 5 ISO 5 ∆p = Cleanroom Class

Shielding

Overlapping steps of lead – no radiation escape No personal expose to lead, all covered, no painting X-Ray Energy requires lead shielding Ray Energy requires lead shielding

The complete tunnel is housed in lead, with special The complete tunnel is housed in lead, with special

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The complete tunnel is housed in lead, with special The complete tunnel is housed in lead, with special sandwich technology sandwich technology stainless/lead/stainless

stainless steel stainless steel lead