Professional Documents
Culture Documents
Equipment for
pharmaceutical
industry
Presentation of the company
SK GROUP Škrlj d.o.o.
Brilliant products
Brilliant products
Equipment Manufacturing of vessel equipment for phar-
maceutical and biopharmaceutical industry
is extremely demanding because of specific
for nature of these products. Our company always
follows special needs of customers from these
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Vertical vessels type TFV
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Vertical mobile vessels type TFM
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Design and equipment of pharmaceutical vessels
Technical specifications:
vertical or horizontal orientation, for fixed installation or mobile
applications
single, double or triple-wall design
cone-shaped, flat or torispherical tank bottom design
stainless steel material: EN 1.4301, 1.4401, 1.4404, 1.4571, 1.4435,
1.4307 and others according to the customer's specifications
basic material surface: 2B(IIIc), 2R(IIId, BA), 1D(IIa)
surface finishing: machine brushed inside and outside, scotchbri-
te, mechanically polished, passivated, electropolished
surface roughness : up to Ra<0,4
delta ferrite content: <1 % (according to order specifications)
Temperature control:
`` laser welded cooling/heating jacket and bottom
`` double jacket with directing coil
`` half pipe coil
Vessel insulation:
`` partial or over integral surface
`` insulation material is mineral wool
`` insulation is covered with outer insulation jacket
Working pressure:
`` vessels for use under atmospheric pressure
`` pressure vessels (from –1 to 10 bar) manufactured according to
the PED Directive (97/23/EC)
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Materials and surface finishing
cold rolled stainless steel with 2B (IIIc) surface according to EN 10088-2 (surface smooth, matt)
irregularities on surface which appear during different manufacture procedures are allowed
2B (IIIc)
roughness of stainless steel (before manufacture of tanks): 0,1μm<Ra<0,5μm
roughness of the product is not inspected
cold-rolled stainless steel with 2R (IIId) surface according to EN10088-2 (surface smooth, polished)
irregularities on surface which appear during different manufacture procedures are allowed
2R (IIId, BA)
roughness of stainless steel (before manufacture of tanks): 0,03μm<Ra<0,1μm
roughness of the product is not inspected
surface brushed with scotch brite cloth weld surface chemically passivated and cleaned, without any
passivated
for this surface finishing the 2B or 2R stainless sheet metal is used additional treatment
(CZZ)
scotch brite minor surface irregularities due to characteristics of the basic weld structure is visible
(SB) material and irregularities which are caused in the course of weld zone is brushed with grain 80
the production process are admissible
striped weld structure is partially visible
roughness of the product is not inspected
(BP) weld zone is partially evened with the surface
sand-blasting surface treatment with CrNi steel beads roughness of the weld surface is not inspected
sandblasted
for this surface finishing, the 2B, 2R or 1D stainless sheet metal is used weld zone is chemically passivated, cleaned and mechanically
(CrNi beads) polished
roughness of the product is not inspected polished
unbrushed
weld structure is visible
brushed surface brushed with abrasive band (C)
roughness of the weld surface is not inspected
K60 (Ra<2,0) different grades of brushing, surface roughness Ra<2,0μm to
Ra<0,6μm brushed weld zone is brushed with grain 120, 220 or 320
K80 (Ra<1,6)
minor surface irregularities of the basic material and irregula- K120 weld structure is not visible
K120 (Ra<1,2)
rities which are caused in the course of the production process
K180 (Ra<0,8) K220 weld zone is evened with the surface
are evened
K320 roughness of the weld surface is inspected and certified
K220 (Ra<0,6) roughness of the product is inspected and certified
brushed and
mechanical polished weld zone is brushed and polished with polishing paste for a
polished surface mechanically polished with felt and polishing paste for high-gloss surface finish
a high-gloss surface finish Ra<1,2
Ra<1,2 roughness of the weld surface Ra<1,2 μm to Ra<0,4μm
different grades of polishing, surface roughness from Ra<1,0
Ra<0,8 weld structure is not visible
Ra<1,2μm to Ra<0,4μm Ra<0,8
Ra<0,6 weld zone is evened with the surface
roughness of the product is inspected and certified Ra<0,6
Ra<0,4 roughness of the weld surface is inspected and certified
Ra<0,4
electropolished
surface electropolished
Ra<1,2
different grades of electropolishing, surface roughness from
Ra<0,8
Ra<1,2μm to Ra<0,4μm
Ra<0,6
roughness of the product is inspected and certified
Ra<0,4
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Quality control
Control procedures:
Verification of conformity of components
Verification of conformity of materials
Liquid penetrant testing (PT probe)
Radiographic examination
Hydrostatic test
Pressure test according to PED 97/23/EC
Determination of delta ferrite content
Surface roughness measuremen and verification
Riboflavin test
Final visual and dimensional inspection
Complete documentation review
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LEK d.d., Ljubljana, Slovenia
For the slovene pharmaceutical company Lek d.d. Ljubljana we have manu-
factured stainless steel pressure vessels for preparation and storage of the
product.
Operating Operating
Type of the tank, volume in liters
pressure temperature
1 Vessels for preparation of purified water PW 5200 L -1/+1,5 bar +5/+120°C
2 Preparation vessel with agitator 400 L -1/+4 bar +5/+150°C
3 Vessel for collecting wetting agent 50 L -1/+4 bar +5/+120°C
Materials:
Parts in contact with media: EN1.4404, AISI 316L
Parts not in contact with media: EN1.4301, AISI 304
Insulation: mineral wool Vessel PW 5200 L
external internal
Surface fine brushed / polished brushed and electropolished, Ra<0,6 μm
Welds brushed and passivated brushed and electropolished, Ra<0,6 μm
Technical data:
Materials:
Parts in contact with media: 2B, EN1.4404, AISI 316L
Parts not in contact with media: 2B, EN1.4301, AISI 304
Insulation: polyurethane Termopor
external internal
Surface brushed Ra<1,2 μm electropolished Ra<0,6 μm
Welds brushed Ra<1,2 μm electropolished Ra<0,6 μm
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Merck Serono S.A., Switzerland
Materials:
Parts in contact with media: EN1.4404
Parts not in contact with media: EN1.4301
Insulation: mineral wool
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Novartis Pharma AG, Switzerland
Technical data:
Materials:
Parts in contact with media: EN 1.4404
Parts not in contact with media: EN 1.4301
Insulation: mineral wool
external internal
Surface brushed K220 brushed and electropolished, Ra<0,6 μm
Welds brushed K220 brushed and electropolished, Ra<0,6 μm
Technical data:
Materials:
Parts in contact with media: EN1.4435
Parts not in contact with media: EN1.4301
Insulation: mineral wool
external internal
Surface brushed K220 and passivated mechanically polished Ra<0,4 μm
Welds brushed and passivated brushed and polished Ra<0,4 μm
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UCB, Belgium
For the global biopharmaceutical company UCB, one of the world’s leading companies in deve-
lopment of biopharmaceuticals, we manufactured various stainless steel vessels. These vessels are
designed to be used for the preparation and storage of pharmaceutical products.
Type of the tank, volume in liters Operating pressure Operating temperature
1 Buffer preparation vessel 2500 L -1/+2 bar +2/+135°C
2 Buffer preparation vessel 1000 L -1/+2 bar +2/+135°C
3 CIP vessel 1000 L atmospheric +2/+95°C
4 Caustic vessel 1000 L atmospheric +2/+95°C
5 Media preparation vessel 1500 L -1/+2 bar +2/+135°C
6 Hold vessel 2200 L -1/+2 bar +2/+135°C
Materials:
Parts in contact with media: EN1.4435, AISI 316L / EN1.4404, AISI 316L
Parts not in contact with media: EN1.4404, AISI 316L
Insulation: mineral wool
Vessel with heating spiral, 1000 L
Surface and welds finishing:
external internal
Documentation and control procedures:
brushed and passivated, Ra<1,5 μm
Surface electropolished, Ra<0,6 μm
lid mechanically polished Construction drawing
Welds brushed and passivated brushed and electropolished, Ra<0,6 μm
Liquid penetrant testing (PT probe)
Surface roughness measuremen and
verification
Cleaning and passivation report
Determination of delta ferrite content
Riboflavin test
Pressure tank calculation according to
AD 2000 Merkblatt
Material certificates according to EN
10204-3.1 and EN 10204-2.2
Pressure test according to PED 97/23/EC
Welding procedure specifications (WPS)
Welder certificates
FDA Certificate
CE Declaration of Conformity according
to PED 97/23/EC
Instructions for use and maintenance
Buffer preparation vessel 2500 L Buffer preparation vessel 1000 L CIP vessel 1000 L Hold vessel 2200 L Caustic vessel 1000 L
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UCB, Belgium
Technical data:
Volume liter 2500
Diameter inside mm 1400
Diameter outside mm 1550
Tank wall mm 1450
Mass of the empty vessel (approx.) kg 940
Operating pressure (vessel) barg -1 / +2
Operating pressure (double jacket) barg -1 / +5
Design pressure (vessel) barg -1 / +3
Design pressure (double jacket) barg -1 / +6,7
Working temerature (vessel) °C +2 / +135
Working temperature (double jacket) °C +2 / +85
UCB, Belgium
Technical data:
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Armeeapotheke, Ittingen, Switzerland
Materials:
Parts in contact with media: EN1.4404
Parts not in contact with media: EN1.4301
Insulation: mineral wool
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LEK (NOVARTIS, SANDOZ), Slovenia
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Novartis Pharma AG, Switzerland
Technical data:
Materiali:
Inside vessel: EN1.4404, AISI 316L
Outside vessel: EN1.4307, AISI 304L
external internal
Surface electropolished Ra<0,4 μm polished Ra<1,0 μm
Welds brushed and electropolished Ra<0,4 μm brushed and polished Ra<1,0 μm
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Eckert & Wellman Anlagentechnik GmbH, Germany
Technical data:
Materials:
Parts in contact with media: 2B(IIIc), EN1.4404
Parts not in contact with media: 2B(IIIc), EN1.4404
Insulation: mineral wool
external internal
Surface scotch brite, lid mechanically polished brushed Ra<1,6
Welds flat brushed flat brushed Ra<1,6
Technical data:
Materials:
Parts in contact with media: EN1.4435, AISI 316L
Parts not in contact with media: EN1.4301, AISI 304
Insulation: mineral wool
Surface and welds finishing:
external internal
Surface scotch brite Ra<0,9 μm brushed Ra<0,8 μm
Welds flat brushed brushed Ra<0,8 μm
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Production capacities
machine for internal and external grinding of tank bottoms and containers
manual, machine (linear and circular) and robotic welding (TIG, MIG/MAG)
automatic sandblasting of large products in the grinding chamber (using Cr-Ni beads)
laser welding
electropolishing
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Manufacturing programme
www.sk-group.biz Winemaking • Wine storage tanks
• Fermenters
• Pneumatic presses
• Temperature regulating equipment
• Labelling machines
MARIBOR
KRANJ BRNIK
LJUBLJANA
NOVA
GORICA
NOVO
BATUJE MESTO ZAGREB
POSTOJNA
TRST
KOPER
Brilliant products
Address:
Škrlj d.o.o.
Dunajska cesta 196 · SI-1000 Ljubljana · Slovenia
Production and administration:
SK GROUP Škrlj d.o.o.
Batuje 90 · SI-5262 Črniče · Slovenia
Tel.: 00386 5 364 35 00
Fax: 00386 5 364 35 25
e-mail: sk@sk-group.biz
www.sk-group.biz
GPS:
13º 46’ 16’’ E
45º 53’ 08’’ N
Katalog_farmacija_2012/05(EN)
The photographs are symbolic. We reserve the right to changes.