Automation in Pharmaceutics - systemagmbh.de · microbial/microbiological contamination to be...

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


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


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


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


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


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


Vaccine production

Project A

Automation of tray feeding and the disinfection

process


• 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


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


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


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.


• 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


Sampling line

Project B

Automation of pallet transport

under GMP conditions


• 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



Room layout


Material lock

Pallets fed by stacker Turn pallet for further conveying

Pallets conveyed further through the sampling area


Sampling line

Self-supporting driving rollers

Entire drive system covered

Position monitoring

Easy cleaning due to smooth

surfaces


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


• 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


Aseptic handling

Projekt C

Automation of the transport and

unpacking of plastic vials


• 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.



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


Handling zone

and sterilisation line in the D area


Handling zone


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


Handling zone


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


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


• 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

Automation in Pharmaceutics - systemagmbh.de · microbial/microbiological contamination to be...

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