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 � 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 � 2
Alternatives, Advantages, Disadvantages, Risks to E-Beam Sterilization 3
E-Beam Decontamination Tunnel Features Design • Operates as independent stand alone system with dedicated PLC, dedicated decontamination system, dedicated pressure control, …) • Integrated H 2 O 2 decontamination system SIS 700 to allow an independent decontamination apart from the filling machine isolator • PLC control with Siemens or Allen Bradley components • 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 / m 2 • • total shielded tunnel: approx. <3.5 tons • total tunnel including all air handling: approx. <5 tons 4
Emitter System & Configuration Triangle configuration � Accommodates 4” Tub Tub � all Tub surfaces exposed - no shadow � distance foil to tub always < 200mm 5
E-Beam Decontamination Beam Decontamination Tunnel Tunnel decontamination performance decontamination performance Courtesy of Linac Courtesy of Linac 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 ���������������������� 6
FILLER WITH SKAN E-BEAM www.skan.ch 7
Application of Sterilization with Electron Beam & Isolator Technology for Syringe Tub Transfer E-Beam Tunnel Isolator System Tubs in Section1 Emitter Section2 Pealing Filling and Closing Tubs out www.skan.ch 8
Zone Concept & Differential Pressure Cascade Zone Concept & Differential Pressure Cascade E-Beam Tunnel Production mode ∆ p = www.skan.ch 0 Pa - 10 Pa > 15 Pa + 25 Pa + 35 Pa + 35 Pa 9 ISO 7/8 ISO 7/8 ISO 7/8/5 ISO 5 ISO 5 ISO 5 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 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 lead stainless steel steel 10
Recommend
More recommend
