Alman İlaç Sanayi Teknolojileri Türkiye 2013 Sempozyumu

Transcription

Food Processing and
Packaging Machinery
Alman İlaç
German Technology
Sanayi Teknolojileri Türkiye 2013
for the Pharmaceutical Industry
Sempozyumu
7 Mayıs 2013
Hotel Polat Renaissance,
Yeşilyurt, İstanbul
May 7, 2013
Hotel Polat Renaissance
Yesilyurt, Istanbul
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ALMAN İLAÇ SANAYİ TEKNOLOJİLERİ SEMPOZYUMU
Değerli Katılımcılar
Dear Madam / Sir,
Alman ilaç sanayi teknolojilerinde „made in Germany“ damgası güvenirliğin, uzun ömürlülüğün
ve teknoloji önderliğinin bir sembolü olarak tanınır.
Bu ünün kaynağı müşterilerimizle uzun soluklu
işbirliklerimize dayanmaktadır. Ürünlerin sürekli
geliştirilebilmesinde en önemli etkenlerden biri,
piyasadaki trendler ve müşterilerin özel ihtiyaçları
üzerine fikir alışverişi yapmaktır.
Pharmaceutical technology made in Germany
is renowned for its for reliability and durability
on the one hand, and on its position of technological leadership on the other.
This reputation has grown over many years of
cooperation with our customers. A key element
here is to share ideas about market trends and
specific customer requirements. This is the
basis for the continuous development of our
products.
7 Mayıs 2013 tarihinde İstanbul’da düzenlediğimiz
„Alman İlaç Sanayi Teknolojileri Sempozyumu“
tüm katılımcılara piyasa perspektifleri, pratik çözümler ve teknolojik trendlere ilişkin karşılıklı bilgi
ve fikir alışverişi imkanı sunmayı hedeflemektedir.
Sunumlar, paneller, molalardaki ve akşam organizasyonundaki enformel sohbetler verimli bir fikir
alışverişi için uygun bir ortam sunacaktır.
Tüm katılımcılara verimli ve başarılı bir sempozyum
diliyorum.
The symposium ‚German Pharmaceutical
Engineering‘ on 7 May 2013 in Istanbul offers
a wealth of information on market opportunities, practical solutions and technical trends. It
also offers many opportunities to conduct this
exchange which is productive for all parties:
during discussions breaks and at the informal
gathering in the evening.
Seize this opportunity!
I wish all participants an inspiring day.
Stephan Mies
VDMA İlaç ve Kozmetik Sanayi Makine ve
Tesisleri İhtisas Departmanı Başkanı
Chairman of the VDMA section ‚Machines and plants
for the pharmaceutical and cosmetics industry‘
SYMPOSIUM ,GERMAN TECHNOLOGY FOR THE PHARMACEUTICAL INDUSTRY‘
Automatik Plastics Machinery GmbH
63762 Großostheim
www.maag.com
MediSeal GmbH
33758 Schloß Holte-Stukenbrock
www.mediseal.de
AZO GmbH & Co. KG
74706 Osterburken
www.azo.de
KORSCH AG
13509 Berlin (Borsigwalde)
www.korsch.de
Robert Bosch GmbH
Packaging Technology
71332 Waiblingen
www.bosch.de/pa
Laetus GmbH
64665 Alsbach-Hähnlein
www.laetus.com
DIOSNA Dierks & Söhne GmbH
49086 Osnabrück
www.diosna.de
Herding GmbH
Filtertechnik
92224 Amberg
www.herding.de
HOSOKAWA ALPINE
Aktiengesellschaft
86199 Augsburg
www.alpinehosokawa.com
IPS International Packaging
Systems GmbH
74564 Crailsheim
www.ips-packaging.com
Dividella AG
Pharma-Verpackungsmaschinen
9472 GRABS
SWITZERLAND
www.dividella.ch
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LEISTRITZ Extrusionstechnik
GmbH
90459 Nürnberg
www.leistritz-extrusion.com
GEBRÜDER LÖDIGE
Maschinenbau GmbH
33102 Paderborn
www.loedige.de
M+W Process Industries GmbH
70499 Stuttgart
www.pi.mwgroup.net
NEUMO GmbH + Co. KG
75438 Knittlingen
www.neumo.de
OPTIMA pharma GmbH
74523 Schwäbisch Hall
www.optima-pharma.com
HERMANN WALDNER
GmbH & Co. KG
88239 Wangen
www.waldner.de
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Program
Program
Konferans dili: Türkçe ve İngilizce. Türkçe-İngilizce simultane çeviri yapılacaktır.
09:30
Kayıt
10:00
Selamlama Konuşmaları S
tephan Mies, CEO Korsch AG ve VDMA İlaç ve Kozmetik
Sanayi Makine ve Tesisleri İhtisas Departmanı Başkanı
Cengiz Celayir, Türkiye İlaç Sanayi Derneği (TİSD)
Yönetim Kurulu Başkanı
Açış Konuşmaları
D
r. Philipp Deichmann, Maiyette Başkonsolos,
Almanya İstanbul Başkonsolosluğu
Dr. Saim Kerman, T.C. Sağlık Bakanlığı,
Türkiye İlaç ve Tıbbi Cihaz Kurumu Başkanı
Plenum Sunumları
10:45
Türkiye İlaç Sanayinde Siyasi Çerçeve ve Ekonomik Potansiyel
Cengiz Celayir, Türkiye İlaç Sanayi Derneği (TİSD) Yönetim Kurulu Başkanı
11:15
Türkiye İlaç Sanayinde Teknolojik Donanım ve Zorluklar
Prof. Dr. Ahmet Araman, ISPE Türkiye Başkanı
11:45
Üretim Tesislerinde Modernizasyon Gereksinimi ve Karşılaşılan Zorluklar
Dr. Ünsal Hekiman, PharmaVision Yönetim Kurulu Başkanı
12:15
Sabah Oturumunun Özeti, Stephan Mies, CEO Korsch AG
Öğleden Sonraki Oturumlar Hakkında Bilgiler, Dr. Peter Golz,
VDMA Gıda ve Ambalaj Makineleri Departmanı Genel Müdür Yardımcısı
12:30
Öğle Yemeği
Teknik Sunumlar – Bölüm A
Oturum Başkanları: D
r. Ünsal Hekiman, PharmaVision Yönetim Kurulu Başkanı;
Dr. Peter Golz, VDMA
13:30
Endüstriyel eczacılıkta öğütüm sanatı
Michael Kuhnen, Senior Sales Manager Pharma & Lab Division,
Hosokawa Alpine AG
14:00
Yenilikçi kaplama teknolojileri (Coating)
Dirk Ramsbrock, Sales Manager Life Science Technology, Lödige
14:30
Katı ilaç üretiminde emniyetli toz tutma teknolojisi
Johannes Götz, Manager International Sales Department (AAD), Herding
15:00
AR-GE çalışmalarında ve üretimde yüksek containment gerektiren örneklere
bakış, Ingo Stammnitz, Sales Director, Korsch AG
15:30
Granülasyon, katı formdaki üretimde izolasyon: Risk analizi ve stratejileri
Ahmed Ben Abdallah, Area Sales Manager, Diosna
16:00
Kahve Molası
16:30
Solid form ürün blisterleme için kontaminasyon çözümleri
Benno Reichert, Area Sales Manager, Mediseal
17:00
Katı dispersiyon üretimi için hot melt extrusion alanındaki son yenilikler ve
yeni dozajlama formları
Albrecht Huber, Head of Business Unit Pharma Extrusion, Leistritz
17:30
Holtmelt extrusion alanında kesintisiz mikro pelet üretimi
Stefan Deiß, Director BU Development & Engineering,
Automatik Plastics Machinery
18:00
Ortak Plenum Sunumu
18:30
Ortak Plenum Sunumu: Dr. Michael Weber, Tetragon Consulting
19:00
Öğleden Sonrası Oturumlarından Sonuçlar, Stephan Mies, CEO Korsch AG
Ardından Gemi Gezisi ve Akşam Yemeği (Kalkış ve dönüş: Polat Renaissance Oteli‘nin iskelesi), Konuk Konuşmacı:
Prof. Dr. Metin Sağmanlı, Alman-Türk Ticaret ve Sanayi Odası Yönetim Kurulu Başkanı
Teknik Sunumlar – Bölüm B
Oturum Başkanları: Prof. Dr. Ahmet Araman, ISPE Türkiye Başkanı; Namık Yener, General Manager Yener &
Yener Engineering Consulting; Dr. Michael Weber, Tetragon Consulting
Solid ve likit ilaç imalatında hammadde besleme otomasyonu
Thomas Stegmeier, Sales Manager, AZO Vital
Moris Alçe, Sales Manager, Alkem
Büyük hacimli parenteral dolum tesisi için tasarımdan gerçekleştirmeye kadar bir örnek inceleme
Dr. Frank Scholl, Director Projects, Robert Bosch GmbH Packaging Technology, Integrated Systems Pharma
Bir biyotek tesisinin gerçekleştirilmesi için somut bir yaklaşım
Josef Kriegl, M+W Process Solutions
İlaç uygulamaları için paslanmaz çelik borular
Harry Jost, Sales Director, Neumo
Steril parenteral solusyonların yüksek potentli aktif madde ile hazırlanması
Dirk Collins, Product Manager Isolators and Containments, Waldner Process Systems
Kahve Molası
Optima pharma steril doldurma ve kapatma sistemleri, dondurarak kurutma yöntemi ve
izolasyon teknolojisi, Klaus Engele, Sales Manager, Optima Pharma
İlaç üretiminde dolum yükseltme ve ambalajlama
Karsten Ehrhardt, Sales Manager Pharma / Healthcare, IPS
İlaç ambalajlamada sürdürülebilirlik
Nicola Vella, Sales Manager, Dividella
İlaç Takip Sistemi: Zorlukları ve Avantajları
Basel Jawich, Laetus
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Programme
Programme
All presentations are held in English will be translated simultaneously into Turkish and vice versa.
09:30
Registration
10:00
Welcome S
tephan Mies, CEO Korsch AG and President VDMA section
¸Plants and Machinery for the Pharmaceuticals and Cosmetics Industry‘
Cengiz Celayir, President of Pharmaceutical Industry Association
of Turkey (TISD)
Greeting addresses Dr. Philipp Deichmann, Deputy Consul General
D
r. Saim Kerman, President, Turkish Pharmaceuticals and
Medical Devices Institution, Ministry of Health of Repuplic Turkey
Plenary session
10:45
Turkey‘s Pharmaceutical Industry – Polical environment and economic perspectives
Cengiz Celayir, President of Pharmaceutical Industry Association of Turkey (TISD)
11:15
Technical challenges faced by the Turkey‘s pharmaceutical industry
Prof. Dr. Ahmet Araman, President ISPE Turkey
11:45
Continous modernisation of production facilities – Necessity and challenges
Dr. Ünsal Hekiman, President Pharmavision San. ve Tic. A.S.
12:15
The morning session – a résumé
Stephan Mies, CEO Korsch AG
The afternoon sessions – what‘s ahead?
Dr. Peter Golz, Deputy Managing Director, VDMA Food Processing Machinery
and Packaging Machinery
12:30
Lunch break
Technical lectures – series A
Moderation: Dr. Ünsal Hekiman, President Pharmavision San. ve Tic. A.S.;
Dr. Peter Golz , VDMA
13:30
The fine art of milling in pharmaceutical industry
Michael Kuhnen, Senior Sales Manager Pharma & Lab Division,
Hosokawa Alpine AG
14:00
Innovative coating technology
Dirk Ramsbrock, Sales Manager Life Science Technology, Lödige
14:30
Safe dedusting technology
for the pharmaceutical production of solida
Johannes Götz, Manager International Sales Department (AAD), Herding
15:00
High containment compression in R&D and production - case studies
Ingo Stammnitz, Sales Director, Korsch AG
15:30
Containment for solid form process (granulation): Risk assessment and strategies
16:00
Coffee break
16:30
Containment solutions for solid blister packaging
17:00
Latest innovations in the field of hot melt extrusion for
manufacturing of solid dispersions and new dosage forms
Albrecht Huber, Head of Business Unit Pharma Extrusion, Leistritz
17:30
Continuous production of micro pellets in the hot melt extrusion
Stefan Deiß, Director BU Development&Engineering,
18:00
Plenary session
18:30
Future requirements for pharmaceutical production
Dr. Michael Weber, Tetragon Consulting
19:00
The afternoon sessions – a résumé, Stephan Mies, CEO Korsch AG
Subsequent Dinner Reception (Bosporus ship cruise), greeting address: Prof. Dr. Metin Sagmanli,
President of German-Turkish Chamber of Industry and Commerce
Greeting address: Prof. Dr. Sagmanli,
President of AHK (Turkish-German Chamber of Industry and Commerce) Istanbul
Technical lectures – series B
Moderation: Prof. Dr. Ahmet Araman, President ISPE Turkey; Namık Yener, General Manager Yener & Yener
Engineering Consulting; Dr. Michael Weber, Tetragon Consulting
Material powder handling in the pharmaceutical production of solids and liquids
Thomas Stegmeier, Sales Manager, AZO Vital
Moris Alçe, Sales Manager, Alkem
From concept to realization - A case study for a large volume parenteral filling facility
Dr. Frank Scholl, Director Projects, Robert Bosch GmbH Packaging Technology, Integrated Systems Pharma
A clear approach to biotech facility realization
Stainless steel tubes for pharmaceutical applications
Compounding of sterile parenterals with highly active substances
Dirk Collins, Product Manager Isolators and Containments,
Waldner Process Systems
Coffee break
Optima pharma sterile filling and capping systems,
lyophilization and isolation technology
Klaus Engele, Sales Manager, Optima Pharma
Upgrade filling and packaging in a pharmaceutical company
Karsten Ehrhardt
Sales Manager Pharma / Healthcare, IPS
Sustainabilitty in pharmaceutical packaging
Track & Trace: Challenges and benefits
Basel Jawich, Laetus
7
8
Technical lectures –
Series A
Teknik Sunumlar –
Bölüm A
The fine art of milling in pharmaceutical industry
Michael Kuhnen, Senior Sales Manager Pharma &
Lab Division, Hosokawa Alpine AG
m.kuhnen@alpine.hosokawa.com
Endüstriyel eczacılıkta öğütüm sanatı
Michael Kuhnen, Senior Sales Manager Pharma &
Lab Division, Hosokawa Alpine AG
m.kuhnen@alpine.hosokawa.com
Hosokawa Alpine is the market leading supplier
of components and turnkey systems to produce
powders, granules and bulk materials for the
chemical, pharmaceutical, food, minerals, metals
and recycling industries.
Hosokawa Alpine, kimya, ilaç, gıda, mineral
ve metal sektörleriyle geri dönüşümlü alanlar
için granül ve toz üretme makine ve sistemlerinin üretiminde ve anahtar teslim projelerinin
uygulamasında dünyanın önde gelen firmalarından
biridir.
İlaç sanayinde tane boyutu, üretilen malzemenin
en önemli özelliklerinden birini temsil etmektedir.
Hosokawa Alpine her çapta parça üretebilen
değişik teknolojilere sahip olduğundan dolayı
bu konuda derin bir bilgi ve deneyime sahiptir.
Sunumda değişik toz üretme tekniklerinin incelik
lerini tartıştıktan sonra, bu sistemlerin ilaç sanayi
için geliştirilen, steril imalat ve biyolojik koruma
kavramlı uygulamarından örnekler verilecektir.
Araştırma ve geliştirme boyutundan başlayıp,
yüksek hacim imalat alanını kapsayan sistemlerimiz için doğru ekipman seçimi, sistem tasarımı ve
optimizasyonun nasıl yapıldığına değinilecektir.
For the pharmaceutical industry, particle size
reduction is one of the key processes. After an
overview about existing milling technologies we
will discuss necessary features for a system design that fulfils pharmaceutical quality standards
including special requirements like sterile milling
and containment technology.
From R&D to production field we will answer the
question, how to select the right milling system
together with a short guidance, how to design
and optimize a milling process.
Innovative coating technology
Dirk Ramsbrock, Sales Manager Life Science
Technology, Lödige
ramsbrock@loedige.de
Since 1980 Lödige produces tailor made tablet
coaters for the pharmaceutical industry. Serving
a widest range of coating applications (from
smallest vegetable seeds to multi- layered tablets
or small medical devices having complex shape
– from sugar and film coating to sophisticated
explosion proof concepts) the classic LHC series is
successfully established.
Now, the pharmaceutical manufacturers are
more and more forced to implement high effective production due to cost reducing measures. By
implementing a couple of innovative ideas Lödige
can now present a high efficient tablet coater
with awesome performance in film coating. This
lecture will present the innovations of Lödige LC
Series.
Yenilikçi kaplama teknolojileri (Coating)
Dirk Ramsbrock, Sales Manager Life Science
Technology, Lödige
ramsbrock@loedige.de
Safe dedusting technology for the pharmaceutical production of solida
Johannes Götz, Manager International
Sales Department (AAD), Herding
johannes.goetz@herding.de
Content of the presentation:
•Overview of dust generating processes in the
pharmaceutical production of solida
• Dust properties
• Requirements on Dust Collectors
• Filtration Efficiency
• ATEX
•Explosion protection Designs: possibilities and
limitations
• Handling of adhesive dusts
• Safe Change of Filter Elements
• Safe Change at Dust Discharge and Disposal
• Examples for installed Dust Collectors
High containment compression in R&D and production - case studies
ingo.stammnitz@korsch.de
The demand for respirator free R&D and production environment is constantly increasing. As a
consequence, additional operator protection during manufacturing and cleaning for high potent
(e.g. hormones) and highly hazardous actives (e.g.
cytotoxics) is required.
The different concepts and their requirements
for contained tablet presses incl. their specific
peripheral equipment will be presented. This will
include both contained as well as contained/
wash-in-place tablet presses. In various case
studies, solutions for typical R&D and production
units will be explained.
9
Katı ilaç üretiminde emniyetli toz
tutma teknolojisi
Johannes Götz, Manager International
Sales Department (AAD), Herding
johannes.goetz@herding.de
•Solida üretiminde toz ortaya çıkaran
proseslere genel bakış
• Toz özellikleri
• Toz filtresi gereksinimleri
• Tozsuzlaştırma verimi
• ATEX
•Patlamaya karşı korumalı dizaynlar :
ihtimaller ve limitler
• Yapışkan tozlara karşı çözümler
• Filtre elemanlarının güvenli olarak değiştirilmesi
•Filtre altında toplanan tozun güvenli
olarak atılması
• Çalışmakta olan toz filtrelerinden örnekler
AR-GE çalışmalarında ve üretimde yüksek
containment gerektiren örneklere bakış
ingo.stammnitz@korsch.de
10
Containment for solid form process
(granulation): Risk assessment and strategies
ben_abdallah@diosna.de
Granülasyon, katı formdaki üretimde izolasyon:
risk analizi ve stratejileri
ben_abdallah@diosna.de
Due to the current situation in the manufacturing of pharmaceutical drugs (Increasing toxicity
of new APIs, increasing number of highly potent
APIs released on the market, …), the development
and establishing of a containment strategy have
to be set to eliminate the risk of contamination
during a granulation process. The assessment can
be done after mastering the following point:
•Signification of the common used designation
OEL, OEB, STEL and calculation of the limits as
LLTWA and STTWA
•Sources of contamination; Risk analysis,
evaluation and elimination
•Containment strategy for laboratory and
production devices
• PAT: elimination of sampling during process
• Cleaning in place (CIP)
İlaç üretiminin bugünkü durumu göz önüne
alındığında (yeni aktif maddelerin toksik olma
derecelerinin yükselmesi, yüksek potentli API’lerin
sayısının artması...) granülasyon sürecinde kontaminasyon riskini elimine etmek için koruma stratejilerinin belirlenmesi gerekiyor. Buna aşağıdaki
noktalar değerlendirilerek karar verilebilir.
•OEL,OEB, STEL tanımlarının önemi ve LLTWA
ile STTWA limitlerinin hesaplanmasi
•Kontaminasyon kaynakları: risk analizi,
değerlendirme, eliminasyon
•Laboratuvar ve üretim cihazları için korunma
stratejileri
•PAT: proses süresince numune alımının
eliminasyonu
• Ekipmanların temizliği
Containment solutions for solid
blister packaging
benno.reichert@mediseal.de
Solid form ürün blisterleme için
kontaminasyon çözümleri
benno.reichert@mediseal.de
As a result of new developments, pharmaceutical formulations are becoming more and more
potent. The protection of the operator, environment and the product itself is more important
than ever.
The selection of a containment solution to provide the necessary protective measures depends in
particular upon the nature of the product being
packaged. Furthermore, current regulations provide little clear guidance.
The focus of the presentation is the response to
these new challenges for solid dose blister
packaging, based upon four examples of technical applications together with an engineering
design study.
These show the practical implementation of
containment solutions for solid dose blister
packaging.
Yeni yapılan geliştirme çalışmalarının sonucu olarak, farmasötik formülasyonlar toksik etkisi yüksek bir yapıya bürünmekte; böylelikle operatörlerin, çevrenin ve ürünün kendisinin korunması
daha da önem kazanmaktadır.
Bu tip toksik etkisi yüksek yapıya sahip
formülasyonların ve operatörün birbirinden korunabilmesi için gereken kontainment çözümünün
hangi seviyede olacağı, ambalajlanacak ürünün
doğasına ve özelliklerine bağlıdır. Bunun yanında
bu konu hakkında şu an bildiğimiz regülasyonlar
çok düşük seviyede rehberlik edebilmektedir.
Sunumun odak noktası, katı form ürün blisterleme
prosesinde kullanılan kontainment çözümlerini,
birbirinden farklı 4 örnek projedeki uygulanan tek
nikleri ve mühendislik dizaynlarını size aktarmak
olacaktır.
Bu 4 farklı uygulama, katı form ambalajlama için
pratikte kullanılmakta olan kontainment çözümleri
hakkında sizlere bilgi verecektir.
Latest innovations in the field of hot melt extrusion for manufacturing of solid dispersions and
new dosage forms
Albrecht Huber, Head of Business Unit Pharma
Extrusion, Leistritz
ahuber@leistritz.com
Katı dispersiyon üretimi için hot melt extrusion alanındaki son yenilikler ve yeni dozajlama formları
Albrecht Huber, Head of Business Unit Pharma
Extrusion, Leistritz
ahuber@leistritz.com
Nowadays more and more drugs have poorly
soluble molecules, that have to be developed into
dosage forms, which can guarantee high and
reliable drug absorption. Different methods are
available to overcome solubility and improve bioavailability. One of the common methods is the
so-called hot melt extrusion.
The advantages of hot melt extrusion are in
detail as follows:
•Enhancement of the dissolution rate and
bio-availibility
• Modifying of drug release profiles
• Robust process, solvent-free process
• Reproducable, continuous process
More and more drugs are used, which are regarded as highly active resp. highly hazardous. This
means specific requirements for such a plant
especially with respect to people protection.
Leistritz has built hot melt extrusion plants
for OEL level 4 and 5 requirements. The typical
technology is here the isolator technology. However, the extruder needs a complete redesign to
be operated inside an isolator in order to fulfill
cleaning and other procedures.
Leistritz has built up a team of qualified people to
cope with the demand of this industry. Extruders
range from 16 to 50 mm diameter and output
rates from 20 g up to 100 kg/h.
Continuous production of micro pellets in the
hot melt extrusion
Stefan Deiß, Director BU
Development&Engineering,
stefandeiss@maag.com
Handling of liquids, melts and bulk solids, as well
as portioning materials into small particles with
consistent shape and size are some of the prerequisites for successful introduction of innovative technologies into pharmaceutical production.
Many people heard about “hot-melt-processing”,
or are even performing such. But what is the
technology background, especially in terms of
material handling?
This paper will outline some very recent innovations in the field of pelletizing technology suitable for pharmaceutical applications.
11
Holtmelt extrusion alanında kesintisiz
mikro pelet üretimi
Stefan Deiß, Director BU
Development&Engineering,
stefandeiss@maag.com
12
Technical lectures –
Series B
Teknik Sunumlar –
Bölüm B
Material powder handling in the pharmaceutical
production of solids and liquids
Thomas Stegmeier, Sales Manager AZO Vital
ste@azo.de
Moris Alçe, Sales Manager Alkem
malce@alkemteknik.com
Solid ve likit ilaç imalatında hammadde besleme otomasyonu
Thomas Stegmeier , Sales Manager AZO Vital
ste@azo.de
Moris Alçe, Sales Manager Alkem
malce@alkemteknik.com
The requirements for pharmaceutical manufacturing processes differ considerably of those of
other industries. Every process and manufacturing step needs to be validated, meaning drugs
have to be produced with the same ingredients,
machines, parameters and processes in a repeatable manner to ensure the required properties
of the end product at all times. If nothing else,
by providing automated and IT based operator
guided processes AZO does contribute to the
achievement of the above requirements and has
broken new ground in the production of drugs
with its systems.
As a medium sized company and a supplier to the
pharmaceutical industry AZO is involved in the
manufacture of the different dosage forms with
the main focus on solids. The key competence
and expertise of AZO is based on raw material
handling and feeding of the key pharmaceutical
processes. For both, the manufacturing of tablets
and sterile solutions solid raw materials are essential. By the means of these two typical drugs
and their production latest raw material handling
and feeding technology should be explained.
İlaç sanayinde katı ve sıvı üretimi için otomatik
besleme sistemleri
İlaç sanayi üretimindeki talepler diğer sanayilere
nazaran değişiklik göstermektedir. Her proses ve
imalat adımının valide edilmiş olması gerekli olup,
ilaç ürünlerinin tekrarlanabilir şekilde, hep aynı
hammadde, makina, parametre ve proseslerle
üretilmesi durumunda, herzaman aynı son ürün
kalitesine ulaşmak mümkündür.
AZO otomasyon sistemleri ve İT bazlı operatör
kontrollü prosesler sayesinde, sayılan gereksinimlerin yerine getirilmesinde ilaç sanayine önemli
katkılarda bulunmuştur.
AZO orta ölçekli bir firma ve bir ilaç sanayi tedarikçisi olarak, özellikle katı formlara yönelik olarak
değişik ilaç ürünlerinin imalatı konusunda faaliyet
göstermektedir. AZO’nun knowhow ve teknolojisi
ilaç proseslerindeki hammaddde otomasyonu ve
otomatik besleme sistemlerine yöneliktir.
From concept to realization - A case study for a
large volume parenteral filling facility
Written by: P.-C. Rehm, F. Hofmann, Dr. Berthold
Düthorn · Presented by: Dr. Frank Scholl, Director
Projects, Robert Bosch GmbH Packaging Technology, Integrated Systems Pharma
frank.scholl2@bosch.com
Büyük hacimli parenteral dolum tesisi için
tasarımdan gerçekleştirmeye kadar bir
örnek inceleme
Hazırlayan: P.-C. Rehm, F. Hofmann, Dr. Berthold
Düthorn · Sunan: Dr. Frank Scholl, Director
Projects, Robert Bosch GmbH Packaging
Technology, Integrated Systems Pharma
frank.scholl2@bosch.com
• People will get an overview about the design
of parenteral filling facility from start of early
planning and project management to implementation.
• A real example will be used to guide the audience through the phases of the project. Based
on the evaluation of products, desired production volume and existing infrastructure
the facility layout, process requirements and
equipment solutions are developed and proposed to the client.
• The project management portion addresses the
project challenges, the collaboration between
planning, equipment provider and customer
and the time scheduling till finalization of the
project.
A clear approach to biotech
facility realization
josef.kriegl@mwgroup.net
Bir biyotek tesisinin gerçekleştirilmesi için
somut bir yaklaşım
josef.kriegl@mwgroup.net
Should we invest on stainless steel equipment or
in single used systems? Should we plan a single
room facility or look for a well segregated layout?
Should we build new or move into an existing,
empty not used structure? Should we built following a classical approach, stick-built, or go for a
modular approach? Should we do our own design
or purchase a complete facility out of the shelf?
These are fundamental question that any biotech
company in Asia must ask when is looking to
create their production capacity. The presentation
will outline how to give an answer to the different alternatives and highlight the rewards of a
ready to use facility.
Stainless steel tubes for pharmaceutical
applications
h.jost@neumo.de
Stainless steel tubes for pharmaceutical, biotechnological and other high purity applications have
always been one of NEUMO’s core businesses.
Today NEUMO holds one of Europe’s biggest and
most comprehensive stocks for high purity tubing
in her home town Knittlingen in South Germany.
Other members of NEUMO-Ehrenberg-Group in
United States,Turkey,Switzerland and Spain contribute with additional substantial stocks in pharma tubes of all dimensional and material grades
used in high purity industries. Our highest quality
is based on long term contracts with Europe’s
and America’s best tube mills. NEUMO is relying
on only a few specialized, accredited and certified
mills to produce our special pharma brands NEUMO Pharmatube ECO, NEUMO Pharmatube S,
NEUMO Pharmatube XS ,Neumo Pharmalloy and
ASME BPE. BioConnect ®, BioConnect Clean Lip®,
BioControl® and Connect S® are developments
for the pharmaceutical industry worldwide.
Details of materials, surfaces and standards are
part of the presentation.
13
İlaç uygulamaları için paslanmaz
çelik borular
h.jost@neumo.de
14
Compounding of sterile parenterals with highly
active substances
dirk.collins@waldner.de
Steril parenteral solüsyonların yüksek potentli aktif madde ile hazırlanması
dirk.collins@waldner.de
Content:
• What means high potent?
• What is the OEL?
• Operator protection versus product protection
• Newly developed transfer system
• Case studies
•
•
•
•
•
Optima pharma sterile filling and
capping systems, lyophilization and isolation
technology
Klaus Engele, Dipl.-Ing. (FH) / Sales Manager,
Optima Pharma
klaus.engele@optima-pharma.com
Optima pharma steril doldurma ve kapatma
sistemleri, dondurarak kurutma yöntemi ve
izolasyon teknolojisi
Klaus Engele, Dipl.-Ing. (FH) / Sales Manager,
Optima Pharma
klaus.engele@optima-pharma.com
OPTIMA pharma: Sterile Filling to the Highest
Standards
Filling lines for pre-sterilized nested disposable
syringes including secondary packaging machines.
Filling lines for vials and bottles including
washers, sterilization tunnels, freeze drying technology and isolator technology.
OPTIMA pharma’dan yüksek standartlarda steril
dolum
Sterilize edilmiş tek kullanımlık şırıngalar için
dolum hatları.
Flakon ve şişeler için yıkama ve sterilizasyon tünelleri, liyofilizatör ve izolatör teknolojileriyle birlikte
dolum hatları.
Upgrade filling and packaging in a
pharmaceutical company
Hr. Karsten Ehrhardt
karsten.ehrhardt@ips-packaging.com
İlaç üretiminde dolum yükseltme ve
ambalajlama
Hr. Karsten Ehrhardt
karsten.ehrhardt@ips-packaging.com
The topic “Upgrade Filling and Packaging in a
Pharmaceutical Company” relates to the necessary steps from manual / semi-automatic
packaging to fully automated packaging by
regarding the specific company related needs,
requirements, challenges and chances. Companies in the situation for need of more production
capacities, quality related needs and to optimize
the existing packaging lines for better efficiencies
instead to invest into new equipment. Harmonization of packaging materials to reduce number
of packaging varieties as well as to upgrade the
production related supply chain.
Yüksek potent ne anlama gelir?
OEL nedir?
Operatör koruma ürün korumaya karşı
Yeni geliştirilen transfer sistemi
Uygulama örnekleri
Sustainabilitty in pharmaceutical packaging
n.vella@dividella.ch
15
İlaç ambalajlamada sürdürülebilirlik
n.vella@dividella.ch
Maintaining an eco-friendly business often
conflicts with driving down costs, but sustainable
packaging may provide the solution that pharmaceutical companies are looking for
Sustainable packaging design is an increasingly
important consideration for pharmaceutical companies. Trends towards increased home administration of therapies drive the need for unit dose and
compliant consumer packaging. Approvals for new
biopharmaceutical products have dramatically
increased the demand for reliable, safe, cost-effective and uniquely identifiable packaging. With
the surge and increased acceptance of pre-filled
syringes, syringe/vial kits and alternative drug
delivery systems, new and innovative packages
are being developed, with highly effective patient
safety and product protection features. Sustainable packaging is attained by utilising an engineered
approach that addresses the entire packaging and
product life cycle, not merely the package itself.
Paper-based engineered packages can offer significant advantages in achieving an eco-friendly and
a high performance package while providing the
least total cost of ownership.
Topics addressed:
• Eco-Friendly and High Performance
• Higher Production Efficiencies
• Accomplishing Specific Packaging Goals
• Eco-Economical Packaging
Track & Trace: Challenges and benefits
Basel Jawich, Aerea Sales Director EEMEA, Laetus
basel.jawich@laetus.com
İlaç Takip Sistemi: Zorlukları ve Avantajları
Basel Jawich, Aerea Sales Director EEMEA, Laetus
basel.jawich@laetus.com
All countries require market authorization for
pharmaceuticals to be sold and most countries
have a national plan defining which pharmaceuticals can be reimbursed. Turkey took a leading
role in addressing fraud in the reimbursement
process by mandating new drug traceability processes. Thus, the motivation to push this traceability process forward is tied to the management
of fraud in the reimbursement process, as well as
to patient safety and further benefits.
One major benefit is to prevent counterfeit. The
WHO (World Health Organization) estimates that
12% of drugs are counterfeit, with this percentage rising to 65% in developing countries. The
international drug counterfeiting market is currently at valued at $40bn and estimated to rise to
$78bn by the end of 2013.
Bütün ülkeler, satılacak ilaç için ruhsat talep
etmektedir ve pek çok ülkede tanımlanan ulusal
bir geri ödeme planı mevcuttur. Türkiye, bu
zorunlu geri ödeme sürecindeki yolsuzluklarla
mücadelede, yeni ilaç izlenebilirlik sistemi (ITS)
ile öncü bir rol üstlenmiştir. Bu ileri izlenebilirlik
sürecini hızlandırmak için motivasyon, hem hasta
güvenliği ve diğer avantajların yanı sıra geri ödemede uygulanan yolsuzluk yönetimine de bağlıdır.
En önemli avantajlardan biri sahteciliğin
önlenmesıdır. WHO (Dünya Sağlık Örgütü) bu
sahte ilaçların oranının %12’ye, gelişmekte olan
ülkelerde ise %65’e ulaştığını tahmin etmektedir.
Şu anda uluslararası sahte ilaç pazarının 40 milyar
dolara ve 2013 yılı sonuna kadar ise 78 milyar
dolara yükseleceği tahmin edilmektedir.
VDMA
Verband Deutscher Maschinen- und Anlagenbau
(Alman Makine ve Tesis Üreticileri Birliği)
Pharmaceutical and Cosmetic Machinery Section
Lyoner St. 18
60529 Frankfurt
Germany
www.vdma.org
İrtibat
Dr. Peter Golz
peter.golz@vdma.org
Destekleyen Kuruluş
Türkiye İlaç Sanayi Derneği
Yıldız Posta Caddesi, İş Bankası Blokları B Blok Da: 1
34349 Esentepe
İstanbul
www.tisd.org.tr
Organizasyon
LinkTurkey
PR|Events|Professional Connections
Çengelköy Mah. Kaldırım Cad. Kuşluk Çıkmazı 2/2
34680 Kandilli/Üsküdar/İstanbul
Phone +90 216 33234 60
Fax +90 216 33234 61
E-Posta info@link-turkey.com
Web www.link-turkey.com
www.vdma.org

Alman İlaç Sanayi Teknolojileri Türkiye 2013 Sempozyumu

Transcription

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