February 12 th 2014 Pharmapack Paris Ludwig Weibel +41 71 351 73 22 [email protected] CH-9104 Waldstatt, Switzerland www.weibelcds.com Innovative flexible primary packaging solutions for reconstitution and drug delivery systems
February 12th 2014
Pharmapack Paris
Ludwig Weibel +41 71 351 73 22 [email protected] CH-9104 Waldstatt, Switzerland www.weibelcds.com
Innovative flexible primary
packaging solutions for reconstitution and drug delivery systems
3
PUBLIC-HEALTH PROBLEM: SAFETY Switzerland1)
70’000 hospital infections cost CHF 250 million each year.
Error-related deaths amongst hospital patients2) double the
deaths caused by influenza, AIDS and traffic accidents together3).
USA4)
400’000 to 800’000 reported needle stick injuries cost hospitals
1 to 3 billion US$ each year – without the cost caused by
subsequent infections4). (a small stick with a hollow needle may carry over more than 20 pathogens4)) References: 1) Patientensicherheit als Public Health-Problem in Zahlen, Patient safety foundation, Fakten
http://www.patientensicherheit.ch/de/ueber-uns/Patientensicherheit/Fakten.html 2) Source: several actual studies, extrapolation for Switzerland 3) Source: Bundesamt für Statistik, Todesursachenstatistik 2007 4) IV Catheter Needlestick Prevention, B. Braun Melsungen AG, several sources cited in document
4
INJECTABLE DRUGS MARKET
Reconstitution System
MiniBag
Carpules 2’600 Mio pcs mostly insulin
and dental
Prefilled Syringes
3’100 Mio pcs market share
stagnating
Ampoules 39’400 Mio pcs
what is the future? Vials
13’400 Mio pcs Vials liquid
8’900 Mio pcs
Vials Lyophilisate 4’500 Mio pcs
Drug Delivery System (prefilled patch pen)
5
EXAMPLES OF DEVICES FOR VIALS
13mm collar
liquid products lyophilised products and solvent
dis
po
sab
le s
yrin
ge w
ith
sta
ked
n
eed
le a
nd
pas
sive
saf
ety
dev
ice
20mm collar
13mm collar
20mm collar
solvent vial, 13mm collar
lyophilisate vial, 20mm collar
13mm collar
20mm collar
13mm collar
20mm collar
3ml LuerLock syringe
10ml LuerLock syringe
5ml LuerLock syringe
20ml LuerLock syringe
transfer elements with drip stop / swabbable valve
6
PATIENT CENTRIC VIEW
Full integration of all functions and parts
The advantage for the end user is a reduction of
• contaminations
• handling errors
• needle stick injuries
and a gain of time
You can differentiate yourself from competition
7
RECONSTITUTION: TODAY/TOMORROW
2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 17 18 19 20 21 22
today 22 steps
tomorrow 8 steps
remove flip cap
1 3 5 6 8 2
open lid => a) closure
opened, b) solvent
squeezed into vial
pierce rubber stopper
extract drug into syringe
remove syringe
7
inject withdraw syringe => automatic protection of needle
disinfect
8
PREFILLED PATCH PEN
needle injection
Drug Delivery System ready to use => patch to skin
disposable part: • container (MiniBag) • port • micropump • injection needle
reusable part: • pump drive • needle insertion trigger • battery • controller
attach disposable part to reusable part
steel cannula withdrawn => soft cannula stays in skin
active microinfusion with micropump
The prefilled syringe of the future may be a prefilled patch pen with automatic needle insertion and controlled drug delivery.
9
MONO OR MULTILAYER FILM
unlimited material
selection
film: any film
structure that
allows thermo-
sealing
port: molded in
different polymers
compatible with
the inner layer
of the film
port
film
film
«classical» «exotic» «simple» «special»
«symmetric» «assymmetric»
10
NEW MANUFACTURING TREND
blown or cast multilayer film
injection molding of parts into cleanroom mother roll
at the cleanroom: mother roll slitting MiniBag forming device assembly
(MiniBag inserted into device)
11
ASEPTIC FILLING (PILOT EXAMPLE) 2. closure
lifted
3. if necessary:
remove remaining air with vacuum
5. close with same
closure
4. fill
1. place MiniBag
system
6. take off filled,
ready to use MiniBag system
12
KEY BULLET POINTS • sustainable and ecologic thanks to a streamlined, hygienic production and
supply chain
• a Patient-centric view leads to pre-filled MiniBags directly incorporated in
a device, allowing innovative solutions for Patient safety and Compliance
• combine different products in a closed system:
MiniBags can be configurated as multichamber bags with multichannel
ports or may be combined via external channels or transfer devices with
vials via transfer devices
• all functions and parts may be included:
the Patient opens only one disposable package
• scalability and versatility allow to brake human medicine boundaries:
dosages from mice to elephants (e.g. from 0.2 to XXX ml)
13
MINIBAG BASED PRODUCT EXAMPLES
Drug Delivery System
Microinfusion-System
Reconstyringe®
intuitive, automatic reconstitution
Squeezer
a totally new way to store and
administer products
disposable part: • container (MiniBag) • port • micropump • injection needle
reusable part: • pump drive • needle insertion trigger • battery • controller
Flyringe®
between ampoules and PFS
drug in MiniBag
14
Thank you
www.weibelcds.com
Weibel CDS - safer, easier and faster drug delivery
Booth 234