|
Sterile Filling
is the critical
stage of any
biopharmaceutical
product.
This seminar is
here is to
present both new
technologies for
filling but also
sterile filling
in isolators,
small scale
filling, ready
to fill
containers,
single use
filling
equipment and
how to set up
extractable and
leachable
studies.
Small scale
filling
equipment will
be displayed
with expert
vendors ready to
demonstrate and
answer
questions.
The
vendors that
will be
attending
are from:
Merck Millipore
(single use
technologies),
MAR (small scale
filling), Ompi
(ready to fill
containers),
ToxiKon (experts
on
extractables).
Anyone
attending
the seminar
will be able
to address
the
following
questions:
- What are
the
equipment
selection
options for
sterile
filling
- How to solve
typical
problems for
sterile
filling
- What single
use filling
equipment is
available
for sterile
filling
- How to
combine
filling and
isolators
- What
specialized
equipment is
suitable for
small scale
filling
- How can I
learn from
the
experience
of others in
detailed
case
studies
Seminar
program:
|
Duration
|
Topic
|
Speaker
|
08:30-09:00
|
Registration
|
|
09:00-09:15
|
Introduction
|
Shlomo
Sackstein
CEO
Biopuremax
|
|
09:15-10:00
|
Ready
to
fill
glass
containers
for
sensitive
drugs,
Glass
Containers
and
analytical
services
needed
for
choosing
the
right
drug
configuration
|
Odra
Pinato
SG
Lab
Analytics
Coordinator,
Ompi
|
|
10:00-10:45
|
New
technologies
in
Aseptic
Filling
|
Sarel
Chen
Tov
CEO,
Biopharmax
|
|
10:45-11:15
|
Coffee
Break
-
Vendor
Demonstrations
|
|
11:15-12:00
|
Small
scale
filling
|
Simona
Berretta
Sales
Area
Manager,
M.A.R.
Spa
|
|
12:00-12:45
|
Single-Use
Technology
in
Final
Fill:
process
design
and
quality
considerations
|
Dr.
Simone
Biel
Field
Marketing
Single
Use
Technology
EU
Process
Solutions,
Merck
Millipore
|
|
12:45-13:45
|
Lunch
-
Vendor
Demonstrations
|
|
13:45-14:30
|
Case
study
–
New
aseptic
fill
finish
pilot
facility
for
Teva
branded
sterile
pipeline
|
Arnan
Ben
David
Director
-
Global
Sterile
Engineering,
Teva
|
|
14:30-15:15
|
Coffee
Break
-
Vendor
Demonstrations
|
|
15:15-16:00
|
How
to
Set-up
Extractable
&
Leachable
Studies
for
Small
Volume
Parenteral
Applications
(Vials,
Syringes
and
Cartridges)
|
Dr.
Dries
Cardoen
Study
director/Project
manager
Extractables
and
Leachables,Toxikon
|
|
16:00-16:30
|
Panel
All
speakers
&
special
guest
participant: Rachel
Shimonovitz, Head
of
Inspectorate,
GMP,
Israeli
Ministry
of
Health
|
Note:
the
program
and
speakers
are
tentative
and
subject
to
change
without
prior
notice.
Target
Audience:
This Seminar is a
perfect learning
session for:
- Engineering
and Project
managers
wanting to
learn
relevant
methods in
the field
- Production
personnel
dealing with
sterile
filling
- Procurement
and
maintenance
persons
wanting to
understand
more
- Quality
responsible
persons who
need
implementation
data
- Validation
managers and
engineers
- Operations
and
logistics
personnel
Participation
Fees:
PDA members -
650 NIS
Non members -
850 NIS
|
Parking:
Parking
will be
available
at Kikar
Atarim
parking
area,
165
Hayarkon
st. Tel
Aviv
Parking
coupon
(40 NIS)
will be
available
at the
hotel
concierge.
|
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