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Let’s Have Coffee.. Tillotts Services will be represented at the following events during 2014. We would be delighted to meet with you. For more information please visit: http://www.biotrinity.com

07 - 09 October 2014 CPhI/ICSE Paris, France

For more information please visit: http://www.cphi.com

INTERVIEW

12 - 14 May 2014 BioTrinity London, UK

NEWSLETTER IN THIS ISSUE Our customers benefit from our collaborations: With our Collaboration Partners we can offer expanded Services and Expertise in the field of Liquid Encapsulation to our customers.

In this edition Karin Strübin interviews Daniel Jeker, Head of Quality Assurance Group Ziefen

Installation of an industrial coater at Tillotts Services: Tillotts Services installed a coating device in order to assure the increasing volumes of Colpermin®, increasing customer requests and to improve the capabilities of our facility.

Daniel, please tell us a little about yourself I live in Ziefen with my wife Marina. We have two grown-up sons. Our black Labrador retriever Nera keeps us busy! In my spare time I like to bike (mountain bike as well as racing bike) and hike during the summertime. In wintertime, you can meet me on the skiing slopes as well as on the cross-country ski runs. I enjoy the fact that I only need 4 minutes by bike to my workplace.

Interview: Daniel Jeker, Head of Quality Assurance

When did you join Tillotts? I’ve been working at Tillotts since 2000 in the Quality Assurance Department.

What I always wanted to say... It is very interesting to work in a pleasant atmosphere so close to the other departments such as engineering, the warehouse, production/ packaging and quality control. I hope that the production site in Ziefen will be upgraded through the increase of production volume and new products and therefore will continue to exist.

Please describe your role within Tillotts

Our customers benefit from our collaborations

Together with my team in Ziefen and the other departments responsible for quality, we make sure that Tillotts conforms to the guidelines of the different regulatory authorities.

Our Services and Expertise in the field of Liquid Encapsulation have been expanded to fulfill our customer needs. Together with our Collaboration Partners we are now able to offer a broad range of services in Contract Research, Contract Manufacturing and Drug Delivery Technologies especially in the Late Discovery, Pre-Clinical and Clinical phases of drug development.

Of which project are you most proud? In QA we are proud that we passed all the audits of our customers as well as those of our public authorities successfully. What will be your next major challenge at Tillotts? To be able to deal with the increasing requirements of quality assurance together with the QA team in Rheinfelden as well as to communicate to the departments that we will still be in the “Quality Boat” together. Furthermore, we will have an audit from our Swiss authorities this year. What was the biggest achievement for you at Tillotts? I was able to witness and contribute to the growth of the company (when I started in the year 2000 we were 56 employees and today we are more than 180…)

Tillotts Pharma AG Tillotts Services, Hauptstrasse 27 4417 Ziefen, Switzerland See us on YouTube:

If you are interested in the Liquid Fill Encapsulation Technology as well as in the manufacturing process of Tillotts Services you have now the opportunity to follow us on YouTube.

T: +41 61 935 28 28

F: +41 61 935 28 29

Late Discovery: In this phase we collaborate with Solid Form Solutions Ltd. (based near Edinburgh, Scotland) who are experts for the API (Active Pharmaceutical Ingredients) characterisation of NCE’s (New Chemical Entities).

Follow us on LinkedIn: Please join our LinkedIn Group “Tillotts Services” on LinkedIn. We will inform you about several forthcoming events as well as the latest news within Tillotts Services.

E: services@tillotts.com

Pre-Clinical and Clinical: Our internal experts from the Analytical and Pharmaceutical Development departments together with the expertise of Qualicaps Europe S.A. (based in Alcobendas, Spain) and Kuecept Ltd. (based near Luton, UK) are able to handle a lot of different projects.

Our customers are very satisfied with the extensive Know-How and Expertise we are able to offer together with our Network of Collaboration Partners.

Issue 11

www.tillotts.com

For more information, please contact us at:

www.tillotts.com


Focus on Technology

All the technical equipment was installed in the new extension to the building with the cooling unit being placed outside it. As we had reached capacity with our existing heating system, a second heater was installed and placed in the existing room.

Within this section we aim to profile a technology area related to our business.

Installation of an industrial coater at Tillotts Services Coating of tablets and capsules is a well-known technology used to achieve a targeted release profile of drugs in the gastrointestinal tract or just to enable gastro resistance for a certain time (see our Newsletter No. 9). For environmental reasons, more and more organic coating is being replaced by aqueous coating. For example Colpermin® (Tillotts own product), is a liquid filled hard gelatin capsule, which is manufactured at Tillotts Services with a gastro resistant coating. In order to assure the supply of increasing volumes of the product and to improve the capabilities of our facility, it was decided to invest in a coating device at Tillotts Services. The project was divided into the following steps:

As we had done a thorough job with the preparatory work, we got approval from the authorities without delay and the work was able to start according to plan. Preparation of the infrastructure, construction of the extension to the building, delivery and installation of all the equipment also went exactly according to plan. The high voltage power line in the ground was fortunately not affected by the earthworks. Installation Qualification, Operation Qualification as well as the startup of the machine went smoothly in cooperation with the staff of Glatt. The training of our staff from engineering as well as from the production department took place during the startup of the system and was completed prior to the performance qualification.

1 Set up design qualification 2 Evaluation of the coater (supplier) 3 Preparation of all infrastructure 4 Installation 5 Qualification 6 Start operation

In a special program of the performance qualification, all critical parameters for the operation of the coater for Colpermin® were checked and the limits evaluated. In the aqueous coating of gelatin capsules we have to, on the one hand, avoid the capsules sticking together because of too high a humidity and, on the other hand, avoid brittleness of the capsules due to too low a humidity. This means that the operational parameters of the coater have to be maintained exactly within a certain range.

All the work was done together with a consultant in charge of project management, as our internal resources were limited. As our main coated product for the last 20 years and more has been Colpermin®, the design qualification was focused on this product. The fact was that a lot of suppliers would have been able to fulfill our technical requirements and at comparable costs. However, based on the high quality of their machine, the good price and the fast response to our queries as well as their location near our company, we decided to install the coating equipment GC 350 Smart from Glatt. Prior to ordering the new equipment we made some successful coating trials on a pilot machine at the Glatt site. Coating needs a lot of auxiliary equipment for the handling of the air. As no space was available in the factory, an extension to the building became necessary. In the following flow chart the principle of the coating process is shown: Air inlet

Air outlet

After the successful qualification of the whole system, the process validation for our first product Colpermin® was started. All the batches of the process validation fulfilled our requirements and the stability of the product can now be tested. With the first results of the stability study, the registration of the second coating site can then be initiated in all countries where the product is on the market.

Preheating Silencer Prefilter Heat recuperation

Drying Cleaning agent

Coater Ventilation

Heating Ventilation Outlet valve

Humidification Inlet valve Intermediate filter Heating

Drain

Coating suspension

Filter

Our staff is happy with the high quality of the whole installation and the interesting work which can be done with this new equipment.

We are ready to offer the coating technology as a valuable new part of our Contract Services.

Filter

Copyright © Tillotts Pharma AG 2014 Colpermin is a registered trademark owned by Tillotts Pharma AG except in the UK and Ireland.

www.tillotts.com


Focus on Technology

All the technical equipment was installed in the new extension to the building with the cooling unit being placed outside it. As we had reached capacity with our existing heating system, a second heater was installed and placed in the existing room.

Within this section we aim to profile a technology area related to our business.

Installation of an industrial coater at Tillotts Services Coating of tablets and capsules is a well-known technology used to achieve a targeted release profile of drugs in the gastrointestinal tract or just to enable gastro resistance for a certain time (see our Newsletter No. 9). For environmental reasons, more and more organic coating is being replaced by aqueous coating. For example Colpermin® (Tillotts own product), is a liquid filled hard gelatin capsule, which is manufactured at Tillotts Services with a gastro resistant coating. In order to assure the supply of increasing volumes of the product and to improve the capabilities of our facility, it was decided to invest in a coating device at Tillotts Services. The project was divided into the following steps:

As we had done a thorough job with the preparatory work, we got approval from the authorities without delay and the work was able to start according to plan. Preparation of the infrastructure, construction of the extension to the building, delivery and installation of all the equipment also went exactly according to plan. The high voltage power line in the ground was fortunately not affected by the earthworks. Installation Qualification, Operation Qualification as well as the startup of the machine went smoothly in cooperation with the staff of Glatt. The training of our staff from engineering as well as from the production department took place during the startup of the system and was completed prior to the performance qualification.

1 Set up design qualification 2 Evaluation of the coater (supplier) 3 Preparation of all infrastructure 4 Installation 5 Qualification 6 Start operation

In a special program of the performance qualification, all critical parameters for the operation of the coater for Colpermin® were checked and the limits evaluated. In the aqueous coating of gelatin capsules we have to, on the one hand, avoid the capsules sticking together because of too high a humidity and, on the other hand, avoid brittleness of the capsules due to too low a humidity. This means that the operational parameters of the coater have to be maintained exactly within a certain range.

All the work was done together with a consultant in charge of project management, as our internal resources were limited. As our main coated product for the last 20 years and more has been Colpermin®, the design qualification was focused on this product. The fact was that a lot of suppliers would have been able to fulfill our technical requirements and at comparable costs. However, based on the high quality of their machine, the good price and the fast response to our queries as well as their location near our company, we decided to install the coating equipment GC 350 Smart from Glatt. Prior to ordering the new equipment we made some successful coating trials on a pilot machine at the Glatt site. Coating needs a lot of auxiliary equipment for the handling of the air. As no space was available in the factory, an extension to the building became necessary. In the following flow chart the principle of the coating process is shown: Air inlet

Air outlet

After the successful qualification of the whole system, the process validation for our first product Colpermin® was started. All the batches of the process validation fulfilled our requirements and the stability of the product can now be tested. With the first results of the stability study, the registration of the second coating site can then be initiated in all countries where the product is on the market.

Preheating Silencer Prefilter Heat recuperation

Drying Cleaning agent

Coater Ventilation

Heating Ventilation Outlet valve

Humidification Inlet valve Intermediate filter Heating

Drain

Coating suspension

Filter

Our staff is happy with the high quality of the whole installation and the interesting work which can be done with this new equipment.

We are ready to offer the coating technology as a valuable new part of our Contract Services.

Filter

Copyright © Tillotts Pharma AG 2014 Colpermin is a registered trademark owned by Tillotts Pharma AG except in the UK and Ireland.

www.tillotts.com


Let’s Have Coffee.. Tillotts Services will be represented at the following events during 2014. We would be delighted to meet with you. For more information please visit: http://www.biotrinity.com

07 - 09 October 2014 CPhI/ICSE Paris, France

For more information please visit: http://www.cphi.com

INTERVIEW

12 - 14 May 2014 BioTrinity London, UK

NEWSLETTER IN THIS ISSUE Our customers benefit from our collaborations: With our Collaboration Partners we can offer expanded Services and Expertise in the field of Liquid Encapsulation to our customers.

In this edition Karin Strübin interviews Daniel Jeker, Head of Quality Assurance Group Ziefen

Installation of an industrial coater at Tillotts Services: Tillotts Services installed a coating device in order to assure the increasing volumes of Colpermin®, increasing customer requests and to improve the capabilities of our facility.

Daniel, please tell us a little about yourself I live in Ziefen with my wife Marina. We have two grown-up sons. Our black Labrador retriever Nera keeps us busy! In my spare time I like to bike (mountain bike as well as racing bike) and hike during the summertime. In wintertime, you can meet me on the skiing slopes as well as on the cross-country ski runs. I enjoy the fact that I only need 4 minutes by bike to my workplace.

Interview: Daniel Jeker, Head of Quality Assurance

When did you join Tillotts? I’ve been working at Tillotts since 2000 in the Quality Assurance Department.

What I always wanted to say... It is very interesting to work in a pleasant atmosphere so close to the other departments such as engineering, the warehouse, production/ packaging and quality control. I hope that the production site in Ziefen will be upgraded through the increase of production volume and new products and therefore will continue to exist.

Please describe your role within Tillotts

Our customers benefit from our collaborations

Together with my team in Ziefen and the other departments responsible for quality, we make sure that Tillotts conforms to the guidelines of the different regulatory authorities.

Our Services and Expertise in the field of Liquid Encapsulation have been expanded to fulfill our customer needs. Together with our Collaboration Partners we are now able to offer a broad range of services in Contract Research, Contract Manufacturing and Drug Delivery Technologies especially in the Late Discovery, Pre-Clinical and Clinical phases of drug development.

Of which project are you most proud? In QA we are proud that we passed all the audits of our customers as well as those of our public authorities successfully. What will be your next major challenge at Tillotts? To be able to deal with the increasing requirements of quality assurance together with the QA team in Rheinfelden as well as to communicate to the departments that we will still be in the “Quality Boat” together. Furthermore, we will have an audit from our Swiss authorities this year. What was the biggest achievement for you at Tillotts? I was able to witness and contribute to the growth of the company (when I started in the year 2000 we were 56 employees and today we are more than 180…)

Tillotts Pharma AG Tillotts Services, Hauptstrasse 27 4417 Ziefen, Switzerland See us on YouTube:

If you are interested in the Liquid Fill Encapsulation Technology as well as in the manufacturing process of Tillotts Services you have now the opportunity to follow us on YouTube.

T: +41 61 935 28 28

F: +41 61 935 28 29

Late Discovery: In this phase we collaborate with Solid Form Solutions Ltd. (based near Edinburgh, Scotland) who are experts for the API (Active Pharmaceutical Ingredients) characterisation of NCE’s (New Chemical Entities).

Follow us on LinkedIn: Please join our LinkedIn Group “Tillotts Services” on LinkedIn. We will inform you about several forthcoming events as well as the latest news within Tillotts Services.

E: services@tillotts.com

Pre-Clinical and Clinical: Our internal experts from the Analytical and Pharmaceutical Development departments together with the expertise of Qualicaps Europe S.A. (based in Alcobendas, Spain) and Kuecept Ltd. (based near Luton, UK) are able to handle a lot of different projects.

Our customers are very satisfied with the extensive Know-How and Expertise we are able to offer together with our Network of Collaboration Partners.

Issue 11

www.tillotts.com

For more information, please contact us at:

www.tillotts.com

Tillotts Services Newsletter 11  
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