Refurbishing - Parenteral Drug Association

Refurbishing
PDA:
A
Global
Ageing Equipment
Association
Norbert Opaczek
Bosch Packaging Services AG
Senior Manager
Service Marketing & Sales Support
Bosch Packaging Services
Industrial Technology
Drive and Control
Technology
Pharma
Confectionery
& Food
Packaging
Technology
Liquid Food
Packaging
Services
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Service - Cycle
Services: Selective bundling of products covers selective needs
Availability based Services
Consulting based Services
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Service Factory
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Agenda
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Definition of Refurbishment
Reason for Refurbishment
Ageing Equipment
Technical Audit
Preventive Maintenance
Obsolescence / Obsolete Parts
Modernization
Refurbishment
Summary
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Definition of Refurbishment
• Refurbishing defines the quality-focused
overhaul and maintenance of the product
(equipment) for the purpose of re-use and
commercialization (=remarketing).
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Reason for Refurbishment
• What are the reasons for Refurbishment?
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High availability (health checks)
Keep state-of-the-art
Legal requirements (e.g. safety)
Requirements from health authorities (FDA, 21CFR)
Ageing staff knowledge
• First of all the operator expects that the high efficiency of
his equipment remains preserved during its whole life
cycle.
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Ageing Equipment
• When do we talk about ageing equipment?
• What is related equipment?
• Refurbished Ampoule Filling Machine FMA100
FMA100 built 1965
FMA100 rebuilt 2006
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Technical Audit
• How do I identify refurbishment needs?
Technical Audit: Periodic health check
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Increase of machine output / OEE
Increase of machine availabilty
Reduction of downtime
Modernizations and upgrades
Improvement of maintenance
performed by operator and
maintenance staff
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Preventive Maintenance
• Requirements for maintenance by the FDA guideline 21
CFR
“Equipment and utensils shall be cleaned, maintained, and, as appropriate
for the nature of the drug, sanitized and/or sterilized … to prevent
malfunctions or contamination that would alter the safety… purity of the
drug product …
Written procedures shall be established … These procedures shall
include… the following:
– Assignment of responsibility for … maintaining equipment;
– Maintenance … schedules…
– A description in sufficient detail of the methods, equipment, and
materials …
– Records shall be kept of maintenance, cleaning, sanitizing, and
inspection…”
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Preventive Maintenance
ePMR – electronic Preventive Maintenance Reports
on a tablet PC
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Reports are filled out on a tablet PC
Maintenance checklist
Record of parameters
Drawings of subassemblies
Pictures of parts
Summary of deviations
Overall evaluation
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PDF-report
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Preventive Maintenance
• Safety checks
• Essential maintenance and
inspection of electrical systems
and electronic control systems:
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Thermal imaging
Switch cabinet cleaning
Ultrasonic testing
DGUV provision 3 inspection
(previously BGV A3)
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Obsolescence
• ob·so·lete
– no longer used because something newer exists: replaced by
something newer
• … are defined as per DIN EN 62402.
– “Obsolescence is change from availability to non-availability …
• Remark: This also includes parts which Bosch decided
to discontinue.
• Obsolescence can lead to a one-to-one replacement or a
modernization kit
• Obsolescence management is recommended
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Obsolete - Parts
Best Practice
Discontinuation of ELAU Motion Control
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Several motion controller components
were discontinued by ELAU.
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Recommendation to stock up parts at
an early stage to prevent machine downtime
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Customers were proactively informed
by Service Letter
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Obsolete - Parts
Best Practice
Components of the TPF (Time-PressureFilling system) no longer available.
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TPF based on MS-DOS
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Upgrade to WinXP
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The latest hardware and operating system
Windows XP Embedded will ensure
both parts availability and service in the future.
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Customers were proactively informed
by Service Letter
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Modernization
• Upgrades for improved performance
• Up-to-date safety features
• Latest technology to overcome
obsolescence issues
• Complete refurbishment programs
• Machine rebuilds and overhauls
• Line reconfiguration and recommissioning
• Equipment relocation
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Modernization
• RABS-Installation for vial line
Built in 1999
Rebuilt in 2006
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Modernization
• Further information on our website:
www.boschpackaging.com
01-2007
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Refurbishment
Filling station upgrade
• Time-Pressure Filling system
to pump trolley with peristaltic pumps
Time
Pressure
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Refurbishment
• Filling station upgrade
– 8 Pump Station on ampoule machine
to pump trolley with peristaltic pumps
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Refurbishment
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Cartridge filling and sealing machine (built 1990, modified in 2009)
Obsolescence of motion control
Change to servo motion control (use for next 10 years)
Plus new features: laser filling,
clean-feed stopper system, sealing station
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Refurbishment
• RABS upgrade for 25 year old vial line
(built 1983, rebuilt 2008)
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Goal:
No human influence during the filling process to avoid particles and
contamination.
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Special features:
RABS-installation in connection with modernizations, retrofits as well as
installation of a new machine.
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Refurbishment
• RABS mock-up at machine/line for air-flow studies
• RABS mock-up model
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Refurbishment
• RABS installation at the machine/line
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Refurbishment
• Access to IPC via door
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Refurbishment
Inline hygiene inspection: holder for Petri dish lid Push loading drawer for tool and Petri dish supply
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Refurbishment
• Stopper supply container
– On sliding rail
– Emptying by dumping
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Refurbishment
• Gripper and tweezer holder
– Best position was defined during mock-up
– Gripper and tweezer are handy
and easy to use
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Summary
• Constantly assess your equipment and
define strategy
• Continuous know-how transfer between
supplier and user
• Regular maintenance and health check
à Supplier relationship is the key factor
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Questions / Comments
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Thank you for your
PDA:
A
Global
kind attention.
Association
Norbert Opaczek
Bosch Packaging Services AG
Senior Manager
Service Marketing & Sales Support

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