What does Sefar have to do with your breakfast - SGVC Auswahl von Filtermedien.pdf · Mechanical...
Transcript of What does Sefar have to do with your breakfast - SGVC Auswahl von Filtermedien.pdf · Mechanical...
What does Sefar have to do
with your breakfast ?
20.11.2007 / S. Goldoni 1
0
7
Preserving
agents
Chemical
Industry
Coffee filter
Filter Elements
Light
Architecture
Diagnostics
Healthcare
Cutlery
Mining
Industry
Sugar
Food
Water
Environment
20.11.2007 / S. Goldoni 2
Marketing
& Sales
Application
Engineering
Manufacturing
Synthetic Filter
Products
Core Competencies
- weaving
- finishing
- making-up
- large product range on stock
- application know-how
- customized products
- global distribution
network
- corporate identity
20.11.2007 / S. Goldoni 3
Filtration Worldwide
Sales Office
Fabrication
Mesh&Fabric
Production
Filtration
Separation of solids from liquids = wet filtration
20.11.2007 / S. Goldoni 5
Little Filtration Guide
1. Overview Solid-Liquid Separation
2. Cake-Filtration
3. Overview Filter Media
4. Woven Filter Media
5. Filter Solution
20.11.2007 / S. Goldoni 6
Filtration Overview
20.11.2007 / S. Goldoni 7
No cake formation !
Dead-end filtration Cross-flow filtration
Filtration Overview
Depth Filtration Surface Filtration
20.11.2007 / S. Goldoni 8
Cake Filtration
bridge building
Filter cake
20.11.2007 / S. Goldoni 9
Filtration by size
Membranes
Needlefelts
Woven fabrics
20.11.2007 / S. Goldoni 10
Woven
Filtermedia
Non-Woven
Filtermedia
Filtration / Separation
Media
Monofilament Fabrics
Multifilament Fabrics
Staple Fiber Fabrics
Knitted Fabrics
Needlefelts
Fleece
Sinterproducts
Membranes
20.11.2007 / S. Goldoni 11
Woven Filter Media => Fibers
monofilament
yarn
multifilament
yarn
staple fiber
yarn
20.11.2007 / S. Goldoni 12
Woven Filter Media => Weave patterns
plain twill PRD = plain
reverse dutch
20.11.2007 / S. Goldoni 13
Finishing: Adapted For The End Use
Washing
Pre - shrinking
Pre - stretching
Heat - setting
Antistatic treatment
Customer-specific
treatments
Calendering
Dyeing
20.11.2007 / S. Goldoni 14
Product Rangemesh opening: 1 - 5000 µm
wire diameter: 24 - 1000 µm
1400 different open mesh fabrics
400 different filtration fabrics
Thousands of tailor-made fabrics and made-up
products
PA monofilament: Ø 24 µm
human hair: Ø 65 µm
20.11.2007 / S. Goldoni 15
Filtration solutions
Customers requirements generally involve
Specific industry requirements
Filter machines and separation systems
Process Technology
Filter media and fabrication
20.11.2007 / S. Goldoni 16
Typical general requirements
Mechanical and chemical stability
Life-time
Filter efficiency
Capacity
No clogging
Good cake release and cleanability
Filter performance
Easy maintenance and filter change
20.11.2007 / S. Goldoni 17
Filter Equipment
20.11.2007 / S. Goldoni 18
Focus on Industry Life Science / Pharma
Sefar customized filter solutions for Pharma API
Manufacturing / wet Filtration
Wet Process Separation including Chemical Synthesis,
Fermentation & Extraction
Liquid Product Polishing
20.11.2007 / S. Goldoni 19
Focus on Equipment
Important separation equipment with filter media
Liner or Peeler
Centrifuge
Bag Centrifuge Filter NutscheHeinkel
Inverting Filter
Centrifuge
20.11.2007 / S. Goldoni 20
Polymer Choice
Standard -> polypropylene
Good chemical resistance
Broad resistance to acid and caustic mixture
Reasonable temperature resistance
Some alternatives available in PHARMA-Grade:
Polyester
Polyamide
20.11.2007 / S. Goldoni 21
Polymer Choice
use of high performance materials like
PEEK, PTFE
high temperature resistance
where overheated steam
(sterilisation) or extreme
drying conditions are required
best chemical resistance
PEEK material available for
best food and bio-compatibility
20.11.2007 / S. Goldoni 22
Fabric solutions
SEFAR TETEX MONO optimal particle retention
good defined pore size
pure surface / cake filtration
less clogging
easy cleaning
SEFAR TETEX MULTI good mechanical resistance
recommended for structure parts
smallest particles retained
due to some depth filtration
20.11.2007 / S. Goldoni 23
Fabric Solution
Clogging / Cleaning Issues
Monofilament Fabric
Multifilament Fabric
20.11.2007 / S. Goldoni 24
Fabric Solution
SEFAR TETEX DLW
optimal particle retention
good defined pore size
pure surface / cake filtration
less clogging
easy cleaning
easier installation / maintenance
better mechanical resistance
included support / drainage
20.11.2007 / S. Goldoni 25
Fabric Solution
SEFAR TETEX DLW
avoids wrinkles and reduces dilatation
reduces installation, maintenance time
integrated backing support with drainage function
20.11.2007 / S. Goldoni 26
Fabric solution
Proposed selection of fabrics for Life Science and Pharma
SEFAR PHARMA Grade Fabrics
Most are successfully used since years in pharmaceutical
application
Others have been optimized for the specific requirements
FDA conformity and extraction tests are defined as
standard specifications
20.11.2007 / S. Goldoni 27
Fabrication Liner Centrifuge
Liners available for all models of horizontal or vertical peeler
centrifuge
Drop-In ready
liners
DLW-liners ideal
for peeler units
with minimum
plow tolerances
20.11.2007 / S. Goldoni 28
Fabrication Liner Centrifuge
Seal design adapted to your
centrifuge filter machine
1 filter fabric
2 support fabric
3 ultrasonic contiweld
4 TETEX DLW options
1
2
1
2
1
2
1
2
4 4
3
a b c d e f
1 2
20.11.2007 / S. Goldoni 29
Special requirements from Life Science
and pharmaceutical industries
Certifications (FDA conformity)
Traceability
Consistency of specs
Cleanliness
Easy handling
20.11.2007 / S. Goldoni 30
PHARMA Grade fabrication
introduction of new fabrication standards in order to avoid
additional contamination of the fabricated filters
central registration of all used supply items and
accessories
all items in contact with product are either FDA-compliant
or limited in quantity to ensure extractable levels do not
exceed a tolerable limit of 1500 mg/m2.
20.11.2007 / S. Goldoni 31
Sefar GMP Guidelines for
PHARMA-Fabrication
Introduction of specific Guidelines that control
Cleanliness / Sanitary control
Quality control / Final inspection
Manufacturing Documentation / Work Instructions
Employee Training
Fabrication Sites
20.11.2007 / S. Goldoni 32
Adapted Fabrication procedures
20.11.2007 / S. Goldoni 33
Enhanced Final Inspection
20.11.2007 / S. Goldoni 34
Restriction of supply items
Only specifically registered items are allowed in PHARMA
fabrication
All product contact items are in conformity with FDA or their
use is limited so that extractable levels do not exceed a
tolerable level of total 1500 mg/m2
If conform items are available on the market they will replace
non conform items immediately after positive technical
evaluation
example FDA-conform glue to cover pin holes on fluid bed
dryers
20.11.2007 / S. Goldoni 35
Extraction proceduresSame as for fabrics !
Based on the extractions according to FDA-regulations
(FDA CFR title 21 part 177) for PES and PA
Extraction solvents:
Ethanol 50% Soxlet at total reflux
Ethanol 96% Soxlet at total reflux
Petrol-Ether Soxlet at total reflux
Water (120°C)
For the routine extraction the extraction with maximum result
but without extraction of oligomers is chosen
20.11.2007 / S. Goldoni 36
Fabrication Documentation
Manufacturer specific inspection report O /
PHARMA Fabrication
DIN 55350 – 18 – 4.2.1
specification sheet including the fabric certifications
20.11.2007 / S. Goldoni 37
PHARMA-Grade packing
Easy identification as a Sefar quality product
Every single item is
wrapped separately
in PE-foil and stored
in the PHARMA box
Reusable PHARMA box
20.11.2007 / S. Goldoni 38
PHARMA labelling
Ultrasonic-welded text
for identifiction and tracing
Non Fading
Non Shedding
No introduction of
additional foreign material
20.11.2007 / S. Goldoni 39
Welding in Fabrication
After thorough evaluation and testing of newest technologies
we replace sewing with optimal welding technologies
(replacement of existing articles only after checking back
with the end user)
No stitching holes
No shedding of fibers from the sewing yarn
No attack of the joint through abrasion
20.11.2007 / S. Goldoni 40
Hungry for more ?
20.11.2007 / S. Goldoni 41