Flexibility As A Key To Optimize Sterile Processes and Production Lines

Speaker
Mr. Michael Kühneisen

Technical Product Manager
Michael.Kuehneisen@bausch-stroebel.de
Webinar feedback highly appreciated
www.bausch-stroebel.de
Mr. Patrick Schösser

Patrick.Schoesser@bausch-stroebel.de
Webinar feedback highly appreciated
www.bausch-stroebel.de
1 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Agenda
Flexible pharma production

1. Flexible in your level of investment
2. Flexible in time to market
3. Flexible in the production process
4. Flexible in the packaging material

What does flexible production mean?
What does flexible mean?
Flexibility is the ability to change or be changed easily according

to the situation.

So the question for us as a machine builder is in which situation

is the need for flexibility?
Flexible in the level of your investment
Flexible in time to market
Flexible in the production process
Flexible in the packaging material

Because flexibility is more than a product feature

Flexible in your level of investment
To be flexible in the level of investment requires the possibility

to upgrade your equipment whenever you need.
This can be done in procurement of new equipment or upgrade

of existing equipment.

When it comes to upgrade your existing equipment B+S offers

you some smart solutions.

Of course each single B+S machine is able to be upgraded with

further size parts or bigger upgrades done by our service
department.
But we want to go one step further.
What would you say when you are able to expand your
equipment instead of replace it?

VarioSys the innovative system with the unique
lock and key principle.
Consisting of a standard isolator and the

individual B+S machine modules
Modules provided by B+S
▪ Blank, multi-purpose module

▪ Semi-automatic processing
▪ Nest filling process - syringes, vials and cartridges
▪ Vials in bulk processing
▪ Ampoules in bulk processing

From one chamber…
Over two chambers…
Up to three chambers…


One chamber
Possible configurations
- Semi-automatic processing
- Nest processing of syringe / vial / cartridge

Two chambers
- Bulk processing of vial (RTU)

Three chambers with tunnel and washer
- Bulk processing of vial (RTU and traditional)
- Freeze drying process

cost Customized VarioSys

Filling line Filling line
Customized Isolator with filling line PSI-L / VarioSys

Flexible in the investment
When we talk about flexible investment we also talk about

scale up / scale out.
Scale up or scale out? What’s the difference?

Scale up: Vertical expansion, e.g. by a bigger production

machine
- Scale up can start with semi automatic tabletop machines
- Semi automatic machines for research or small batch production
- Same technologies in tabletop machines as in fully automated machines

E.g.: AdvancedFill for minimal product loss, or same dosing systems
- Scale up of experience
- Scale up from semi automatic tabletop machines to VarioSys

Scale out: Horizontal expansion e.g. more of already existing

production modules
- Avoiding of the tech transfer in general by using identical machines
- Minimal risk to product quality or process performance
- Flexible in the location of the machine
- Reacting quickly on the product life cycle or demand by just

buying additional standardized machines
- Manufacturing scale decisions can be done much
closer in time when product is actually needed
- Investment on Demand
- E.g. Adding similar semi automatic tabletop machines ,

or VarioSys modules

A fast time to market becomes more and more important.
- B+S actions:
- Optimization of internal processes
- Standardizing of parts and variants
- Pre-configuration and reduction of options to an useful amount
- Customers can profit more from our experiences by wasting less time for clarification at
the same time
- Increasing number of machines with a shortened delivery time
- For the following products, B+S can now offer an even more attractive and on schedule
delivery

Semi automatic tabletop machines:
Delivery time of a few weeks with pre-configurated equipment

VarioSys:
Delivery time of
several months with
pre-configurated
equipment.

Syringe filling line featuring SFM5110:
Delivery time less than one year

with pre-configurated
equipment.

Our latest invention in ophthalmic filling and closing, the

FVK50400:
Delivery time of
approx. a year with
pre-configurated
equipment.

// You have specific requirements and needs? Then we are

still perfectly in line with you! //
On request, we will be pleased to examine the possibility of

customized solutions, e.g. for similar packaging materials,
specific process requirements, higher output etc.

To look in the future with serenity you need a flexible

production process

At the beginning we heard how flexible VarioSys is.

But the flexibility doesn't stop at the level of investment.
With this system you are able to realize many different line
configurations with one infrastructure.

Vial processing Freeze drying

with tunnel and freeze drying
(up to 3.600 pc./ h)
▪ Filling Crimping
Washing ▪ Stopper insertion
Syringe processing Freeze drying

with RTU packaging material
Tub debagging
(up to 4,500 pc./ h)
Sterilizing
Lid and liner ▪ Filling

Washing removal ▪ Stopper insertion

Freeze drying
▪ Filling Crimping
Washing ▪ Stopper
insertion
Freeze drying
Tub debagging
Sterilizing
Lid and liner ▪ Filling

Washing removal ▪ Stopper insertion

Different dosing systems – why?
Each system has its features and advantages:
Rotary piston pump → High dosing accuracy
Peristaltic pump → Disposable filling technology
Time/pressure dosing → Broad processing range
→ There is no perfect dosing system available that covers all possible requirements
To be highly flexible a combination of several

dosing systems is needed

B+S Multi Dosing System
+ Up to 3 dosing systems
+ Flexible combination of the different systems
+ Subsequently expandable
+ User friendly and easy accessible
+ Space saving design
+ Proven technology with a new look

The needs of your customers are also our needs.
Different packaging material on one line becomes more and

more state of the art.
- Not just in the small batch segment.

With our brand new product family we have a further solution

for the maximum of flexibility.

35 – 100mm 40 – 90mm 0,5 – 10ml 12.000 pcs./h 100% IPC

16 – 47mm 7 – 14mm 6,85 – 17,05mm

The same stoppering principle for vials and syringes.

The height adjustable scale is just one clever detail to realize

this kind of flexibility.

Also the denester is able to process all different container

types. This gives us the flexibility in the whole line.

Your benefits
Processing of
GMP and FDA High process
various RTU
compliant design reliability
containers
Service
Time efficent optimized 100% IPC
Ready to meet
Suitable for future
Minmized
an isolator challenges
Product Loss

Thank you for your attention
Mr. Michael Kühneisen
www.bausch-stroebel.com Technical Product Manager
Michael.Kuehneisen@bausch-stroebel.de
www.variosys.com
Mr. Patrick Schösser

Detailed Information
and FAQs Patrick.Schoesser@bausch-stroebel.de

Flexibility As A Key To Optimize Sterile Processes and Production Lines

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Speaker

Mr. Michael Kühneisen

Webinar feedback highly appreciated

Mr. Patrick Schösser

Webinar feedback highly appreciated

1 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Flexible pharma production

2 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

What does flexible production mean?

What does flexible mean?

Flexibility is the ability to change or be changed easily according

3 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

So the question for us as a machine builder is in which situation

Flexible in the level of your investment

Flexible in time to market

Flexible in the production process

Flexible in the packaging material

4 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Because flexibility is more than a product feature

5 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

To be flexible in the level of investment requires the possibility

This can be done in procurement of new equipment or upgrade

6 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

When it comes to upgrade your existing equipment B+S offers

7 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Of course each single B+S machine is able to be upgraded with

But we want to go one step further.

8 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Consisting of a standard isolator and the

Modules provided by B+S

▪ Blank, multi-purpose module

9 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Over two chambers…

10 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

11 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

12 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

13 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

14 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

cost Customized VarioSys

Customized Isolator with filling line PSI-L / VarioSys

15 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

When we talk about flexible investment we also talk about

Scale up or scale out? What’s the difference?

16 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Scale up: Vertical expansion, e.g. by a bigger production

- Semi automatic machines for research or small batch production

- Same technologies in tabletop machines as in fully automated machines

- Scale up from semi automatic tabletop machines to VarioSys

17 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Scale out: Horizontal expansion e.g. more of already existing

- Reacting quickly on the product life cycle or demand by just

- E.g. Adding similar semi automatic tabletop machines ,

18 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

A fast time to market becomes more and more important.

- Increasing number of machines with a shortened delivery time

19 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Semi automatic tabletop machines:

Delivery time of a few weeks with pre-configurated equipment

20 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

21 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG

Syringe filling line featuring SFM5110:

Delivery time less than one year

22 © Bausch+Ströbel Maschinenfabrik Ilshofen GmbH+Co. KG