Upload
phamngoc
View
218
Download
0
Embed Size (px)
Citation preview
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 1
Ideas for and Benefits from Semiconductor Industry
Automation in Pharmaceutics
Heinz Martin Esser, Roth & Rau - Ortner GmbH
Josef Ortner, Ortner Reinraumtechnik GmbH
7. Innovationsforum for automation
22.01.2010
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 2
The companies at glance
Ortner Reinraumtechnik
Cleanroom technology
• Innovative cleanroom facilities and products like
material and personal vacuum locks
• Cleanroom services like parts cleaning and
maintenance
• Industries: Pharmaceutical , Life Science, Food,
Semiconductor
Roth & Rau – Ortner
Service provider and automation solutions
• 24x7 support (installation, maintenance, repairs of
production and logistic equipment)
• RFID technology and intelligent storage and
transport systems
• Industries: Photovoltaics, Semiconductor,
Pharmaceutical
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 3
Microelectronics
The invention of microelectronics and its breath-taking advancement towards
ever-smaller structral widths brought about a natural need for particle-free air for
all systems and processes.
Main criterion: particle-free processes and environments
Medical and pharmaceutical industry
A very long time ago, the medical and pharmaceutical industry discovered that
cleanliness and safety demand surfaces to be disinfected and
microbial/microbiological contamination to be avoided.
Main criteria: strict preventive measures, disinfection and sterilisation
Semiconductor and pharmaceutical
industry basics
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 4
Semiconductor and pharmaceutical
industry basics
Semiconductor
Cleanroom classes
ISO 1-8 / Fed. Std. 1-100.000
Directives and standards
ISO /Semi Standard / factory
standards etc.
Cleanliness required
Particles / solids /gases
Pharmaceuticals
Cleanroom classes (ABCDE)
A/B = ISO 5 / Fed. Std. 100
C = ISO 7 / Fed. Std. 10.000
D = ISO 8 / Fed. Std. 100.000
Directives and standards
GMP Guidelines / Annex / ISO /
pharmaceuticals acts / HACCP /
offical requirements / national laws
etc.
Cleanliness required
Germs, viruses, spores, fungi /
prions
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 5
Parallels and differences
Semiconductor
Cleanrooms
Large open rooms
High-level change of air, 50-600 times
Laminar/rectified flows (for ISO 1-4)
Simple gate processes
Transparent inward/outward transfer
processes
Simple cleaning
Usu. large no. of persons
Hidden areas norm. non-critical
Quick and easy qualification
Pharmaceuticals
Cleanrooms
Many small and medium-sized rooms
Low-level change of air, 10-100 times
Turbulent in-room flow (rare laminar
flows)
Complex and multiple gating
processes
Closed - non-tranparent -
inward/outward transfer processes
Very complex cleaning (validated
processes)
Small no. of persons
Hidden areas highly critical
Qualification takes a long time and is
very complicated
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 6
Parallels and differences
Semiconductor
Engineering
Highly flexible and short-term planning
Approx. 5-15% of the investment go
into engineering
Automation
Very high level of automation
Transportation is increasingly fully
automatic
Cleanability limited to particles
Materials have low priority. The focus
is on particle abrasion.
Pharmaceuticals
Engineering
Long and complex planning and
approval processes
Approx. 15-50% of the investment go
into engineering
Automation
Only equipment area has high level of
automation
Logistics mainly marked by manual
transportation
Prime focus is on cleanability
Much attention is paid to the choice of
materials and their germ formation
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 7
Vaccine production
Project A
Automation of tray feeding and the disinfection
process
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 8
• The existing production was designed for 900 eggs. New requirements were to
double the output while leaving the room situation unchanged.
• Incubated eggs are needed to produce the vaccine.
• Prior to inward transfer, dedicated disinfection equipment is applied to spray the
eggs with alcohol.
• Each processing lot processes 1800 eggs.
• The entire process is validated and must not be modified in any of its segments.
• The disinfection equipment and the drying tunnel to be explosion-proof.
• The entire processing cycle (1800 eggs) to be completed within 90 minutes.
• Transportation, storage and processing are performed in cleanroom class A/B.
Description of project / task
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 9
Drying tunnel
Trays holding 120 eggs each
pass through the drying tunnel to
dry off the wet alcohol
The drying tunnel discharges a
total of 15 trays at 2-minute cycle
intervals
Tray recognition and drying
tunnel process control are fully
automatic
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 10
Conveyor line
The trays are stored alongside
the conveyor system
The entire conveyor line has
qualified as cleanroom class
A/B
Each tray is scanned at its bin
location
There are three laminar-flow
workstations for processing
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 11
Position lifting lines
Upon operator request, the trays are automatically
conveyed to the requested LF workstation.
At the LF workstation, the trays are lifted
and can be pulled over to the work top
without obstruction.
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 12
• Production capacity increased by 100%
• Trays are fully automatically conveyed to each LF workstation
• 1 person (MRP controller / setup engineer) made redundant for the processing
process
• Drive technology integrated in the conveyor lines
• No extra fitted hardware inside the clean room
• Perfect cleanability
Results
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 13
Sampling line
Project B
Automation of pallet transport
under GMP conditions
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 14
• In a restricted room area, a cleanroom zone will be established for the taking
and registering of pharmaceutical raw material samples.
• The cleanroom zone consists of a human lock, two material locks, and a
sampling cabin.
• Raw materials are transported on aluminium pallets holding different kinds of
loading units (barrels, sacks, tubs, bottles).
• The pallets may hold a weight of up to 1500 kg.
• Materials flow in one-way traffic
• 1 inward transfer gate
• 1 outward transfer gate
• The pallets are handled by stacker trucks
• The entire transportation to be designed as a semi-automatic process.
• Cleanroom classes are set as E to D to C to B+
• Rooms and system components to be easily cleanable
Description of project / task
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 15
Room layout
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 16
Material lock
Pallets fed by stacker Turn pallet for further conveying
Pallets conveyed further through the sampling area
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 17
Sampling line
Self-supporting driving rollers
Entire drive system covered
Position monitoring
Easy cleaning due to smooth
surfaces
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 18
Sampling line
Ease of operation
Pallets automatically
conveyed to outward transfer
point
Pallets automatically picked
up at inward transfer point
Roll-up gates actuated by
conveyor system
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 19
• The sampling line could be established in a warehouse without cleanroom
environment
• There is very little logistic effort in in-bound and out-bound deliveries
• The system accepts a stock of 3 pallets for the sampling process
• Automation helped to reduce the number of persons required for the sampling
process from 3 to 2
• Perfect cleanability of the line
Results
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 20
Aseptic handling
Projekt C
Automation of the transport and
unpacking of plastic vials
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 21
• A fully-automatic sterilisation and filling line fills vaccines into glass vials. Lots of
300 glass vials are passed through a thermal tunnel steriliser and from there to
the aseptic filler line.
• A future option is to include the same size and quantity of plastic vials. The
plastic vials cannot be sterilised thermally and must therefore be and remain
sterile during handling and transportation.
• The aim is to use the same line to convey the plastic vials to the filler line without
contamination. Further handling will be performed in an isolator.
Description of project / task
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 22
Flow of materials
The trays are delivered in
three-level packaging
The package at the next level
must not be touched
Prior to entering the A area,
the trays are again sterilised
by means of UVc
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 23
Handling zone
and sterilisation line in the D area
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 24
Handling zone
and sterilisation line in the D area
4.1…Hot-air tunnel
4.2…Conveyor system
4.3…Charging carriage
4.4…Waste disposal
4.5…Conveyor
23.1…Feeder line
23.2…Worktop
23.3…Lever adjustment
23.4…Opening for waste
23.5…Waste container
23.6…Cleanroom castors
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 25
Handling zone
and sterilisation line in the D area
The conveyor line will be used for
"plastic vials" process only
Transportation by conveyor line
installed in the sterilisation line
Conveyor line to assemble and
disassemble easily
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 26
Handling and automatic feeding
of vials in the isolator area
29.1…Door 1 with 2 gloves
29.2…Door 2 with 1 glove
30.1…Partition window
30.2…Mouse hole
28.1…Punched manipulation surface
(across entire working area),
in order not to obstruct LF and
not to cover the suction inlet
28.2…Waste disposal opening
28.3…Air return holes for LF lid
Ortner Reinraumtechnik GmbH / Roth & Rau - Ortner GmbH 7th Innovationsforum for automation 22.01.2010 / 27
• Automation system for the pharmaceutical industry are highly complex
and must take heed of both the technical side and the microbiological
side.
• The demand for automation in the pharmaceutical industry is steeply
increasing.
• A basic requirement is to know and obey all pharmaceutical directives
and GMP guidelines.
• Systems provided by the semiconductor industry are often ideally suited
to the needs of the pharmaceutical industry without much need for
adaptation (conveyor systems, fire lobbies, locks etc.).
Conclusions