baju steril austar pharmaceutical & medical consumables-20140324
DESCRIPTION
baju steril di farmasiTRANSCRIPT
-
PHARMACEUTICAL &
MEDICAL CONSUMABLES
-
Cleanroom contamination control products & Sterility assurance 5.
Cleanroom Stainless Steel Products 4.
Laboratory Equipment 3.
Cleanroom Products 2.
ATMI Ultraclean Sterile Packaging 1.
Index
-
ATMI-AUSTAR
ATMI life science and Austar Ltd. established a joint venture ATMI-Austar packaging Technology (Beijing) Co.,Ltd as a advanced production technology, production management and equipment are all provided by ATMI Life science.
Factory facilities conform to EU standards with ISO 5 production environment, perfect quality system, high -quality staff, and customer change notification system to provide guarantee for high quality and uniform products.
-
Ultraclean PE bags/Film
Tyvek & HDPE bags/Roll
Ultraclean Sterile LDPE Freeze-Dry Film
Powder Transfer Vessel/Clean Steam Transfer Vessel
IntergrityTM 2-D Bioprocess Vessel
IntergrityTM 3-D Bioprocess Vessel
ATMI-AUSTAR Product list
-
Application:
For packaging and /or gamma sterilization of :
stoppers, caps and closures
API,Medical powders
Vials and containers
buffers, media
Filters
Medical devices
Cleanroom garments
Syringe components
Organs
5
Ultraclean PE bags
-
6
Ultraclean PE bags
Highlights & Benefits
Low visible and subvisible contaminants level
Low bioburden and endotoxin level
Low leachables and extractables level
Certified cleanliness level
Improved process efficiency
Pre-sterilized bags available upon request
(gamma irradiated at 25 kGy, certified)
Flexibility towards customized products
-
LDPE film is compliant to: FDA Title 21 Code of Federal Regulation 177.1520 Olefin polymers EU Directive 2002/72/EC relating to plastic materials and articles intended to
come into contact with foodstuffs and its amendments
USP , biological reactivity test in vivo, class VI
USP , biological reactivity test in vitro
USP , physicochemical test plastics
EP monograph 3.1.3, Polyolefins
EP monograph 3.1.4, Polyethylene without additives for containers
for parenteral and ophthalmic preparation
EP monograph 3.2.2, plastic containers and closures for pharmaceutical use
LDPE film is Animal Derived Component Free (ADCF)
7
Ultraclean PE bags
-
Order Information:
8
Ultraclean PE bags
specification size(WLT)m packaging
PEF-BS-550750100 5507500.1 50pcs/double bag;300pcs/carton
PEF-BS-10001200100 100012000.1 30pcs/double bag;180pcs/carton
-
9
Tyvek & HDPE bags/Roll
Application
For Steam, EO, Gamma irradiation Sterilization of :
stoppers, caps and closures
vials and containers
syringe components
stainless steel lab or process equipment
Medical devices
Cleanroom garments
-
10
Tyvek & HDPE bags/Roll
Benifits
Ultra pure & clean bag with low particle, bioburden & endotoxin level (certified cleanliness level)
Sterilization indicator switching color when exposed to Steam
Strong bag with high resistance to tear and puncture
Outstanding resistance to microbial penetration
High sterility integrity until package is opened
Increased process efficiency
-
11
Tyvek & HDPE bags/Roll
Highlights & Features Vertically integrated production process with in-house extrusion of the
HDPE from certified virgin resins without the use additives in ultra clean environment
In-house cleaning of uncoated Tyvek 1073B
Production in ISO class 5 cleaning rooms
cGMP certified and focussed company, exclusively servicing the life sciences industry
Easy-Tear option for better opening and sealing
Standard items available from stock
Flexibility towards customized products
Change notification policy in place
Dye-penetration test (methylene blue) to show packaging integrity
-
Specification
Cleansteam Bags
12
Ultraclean PE bags
specification Size(WL)mm Packaging
TY8E16P0000-0001 200x300 100pcs/double
bags 10bags/carton 1000pcs/carcon
TY8E16P0000-0002 320x450 100pcs/double
bags 10bags/carton 1000pcs/carcon
TY8E16P0000-0003 400x500 100pcs/double
bags 7bags/carton 700pcs/carcon
TY8E16P0000-0004 500x650 100pcs/double
bags 5bags/carton 500pcs/carcon
TY8E16P0000-0005 1200x120 25pcs/double
bags 15bags/carton 375pcs/carcon
TY8E16P1148-0001 900x900 25pcs/double
bags 20bags/carton 300pcs/carcon
-
13
Ultraclean Sterile LDPE Freeze-Dry Film
Benifits Low visible and subvisible contaminants level Low bioburden and endotoxin level Low leachables and extractables level Certified cleanliness level High product recovery Improved process efficiency Flexibility towards customized products Save energy, labor cost and, production time, energy cost. Pre-sterilized bags available upon request (gamma irradiated at 25 kGy,
certified)
-
14
Ultraclean Sterile LDPE Freeze-Dry Film
Specification:
Size(WLT)mm packaging
UP1-BS-9501060100 95010600.1 30pcs/double bag; 10bags/carton
-
15
Powder Transfer Vessel
/Clean Steam Transfer Vessel
Applications
Integrity PTVs Powder Transfer Vessels are widely utilized in the biotechnology and classical pharmaceutical industries at all process
scales, from research to high-volume manufacturing. Applications
include contained transfer, storage or shipping of:
Dry powder media Filter aids Buffer salts Excipients
Rubber Stoppers Flip caps
-
16
Powder Transfer Vessel
/Clean Steam Transfer Vessel
Key Benefits Flexible bag design is easy to manipulate and offers good ergonomics Anti-static dissapative materials reduce powder loss and explosion risk Tri-clamp connectors give broad compatibility and superior process seal to
stainless steel or single-use receptacles
High product recovery (typically >99.95%) Superior containment improves process integrity and prevents powder from
escaping into the workspace
Vessel contents are clearly visible Eliminates the need for cleaning and validation, and the associated waste and
delay
Compatible with high-containment split butterfly valve technology( valve) and other third-party containment devices
Small size for ease of storage
-
Efficient movement and storage of liquids is critical to modern biotechnology processes.
The deployment of single-use containers for
this task has become ubiquitous in recent
years because they reduce risk while also
driving down costs in comparison with
traditional stainless steel equipment.
17
Intergrity 2-D Bioprocess Vessel
-
At the heart of ATMIs Integrity systems and products is Integrity TK8 film, a state-of-theart
multi-layer gas-barrier polymer laminate. The
product-contacting layer of TK8 film is blow
extruded in-house by ATMI under cleanroom
conditions using medical-grade ultralow-density
polyethylene resin, then laminated to create a
gas barrier film of exceptional cleanliness,
strength and clarity that is animal derived
component free (ADCF) and complies fully with
USP Class VI requirements.
18
Intergrity 2-D Bioprocess Vessel
-
19
Intergrity 2-D Bioprocess Vessel
Highlights
State-of-the-art designs and materials
Manufactured on automated equipment under ISO
Class 5 (class 100) cleanroom conditions
Suitable for any storage application virtually
Standard and custom configurations available
Integrity tested using ATMIs advanced whole-bag
testing technology
Universal TK8 bioprocess film
-
20
Intergrity 3-D Bioprocess Vessel
ATMIs Integrity 3-D Bioprocess Vessel (BPV) products have been developed to meet the demand for cost-effective, scalable single-use liquid storage containers that are compatible with ATMIs market-leading range of single-use mixing and bioreactor technologies.
-
21
Intergrity 3-D Bioprocess Vessel
At the heart of ATMIs Integrity systems and products is Integrity TK8 film, a state-of-theart multi-layer gas-barrier polymer laminate. The product-contacting layer of TK8 film is blow extruded in-house by ATMI under cleanroom conditions using medical-grade ultralow-density polyethylene resin, then laminated to create a gas barrier film of exceptional cleanliness, strength and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements.
-
22
Intergrity 3-D Bioprocess Vessel
Highlights
State-of-the-art designs and materials
Manufactured on automated equipment under ISO Class 5 (class 100) cleanroom conditions
Suitable for any storage application virtually
Standard and custom configurations available
Integrity tested using ATMIs advanced whole-bag testing technology.
Universal TK8 bioprocess film
-
Wipers: Microfiber wiper: MicroPolx 2750 Wide sealing microfiber wiper
Sealed-edge microfiber wiper
Polyeaster wiper: LTK3000I, LTK3000E and LTK 2020
Non-woven wiper
Cleanroom paper Cleanroom swabs Cleanroom access mats Mopping system Cleanroom mop Cleanroom gloves Cleanroom clothes/underwear/Boots Shoes cover machine
23
Cleanroom Product list
-
Recommended for using in ISO Class 4-5 (Class 10-100) Cleanroom.
Works well with IPA and other solvents
Excellent absorption with de-ionize water and oils.
Smooth texture is ideal for cleaning delicate part, pre-cleaning, degreasing,
polishing & buffing
paintwork, plates & lenses
Its physical attributes make it ideal for using in critical manufacturing
environments of the following applications:
TFT-LCD
Hard Disk Drives
Semiconductors
Pharmaceutical
24
MicroPolx 2750
-
25
MicroPolx 2750
ORDER INFORMATION:
Product Item Number Size/Metric Shts/Pk Pks/Cs
MicroPolx 2750 MPX275.0909.10 9x9/23x23cm 100(stack) 10
-
Material: Polyester and nylon blended micro denier continuous filament yarn Cutting method: Sealed cut Basic weight ( g/ m2 ) 175 5 Size ( Inc. ): 12 12 ( 5) ; 9 9 ( 5) Absorbency : Sorptive capacity ( ml/m2 ) : 330 ; Sorptive rate ( Sec ) : 3
ION ( ppm ): Sodium ( Na+ ) 0.5 ; Potassium ( K+ ) 0.5 ; Calcium ( Ca2+ ) 0.5 ; Chloride ( Cl- ) 0.5 NVR ( ppm ) : IPA extract 500 ; DIW extract 500 LPC ( counts/ m2 ) 0.5um 10 106 Dry flex test 0.3um ( counts/ft3 ) 9 9 300 ; 12 12 500 Package 12 12 100 Pcs/Bag 10 Bags/Ctn. 9 9 100 Pcs/Bag 10 Bags/Ctn.
26
LTK3000I
-
Material: Polyester and nylon blended micro denier continuous filament yarn Cutting method: Sealed cut Basic weight ( g/ m2 ) : 225 10 Size ( Inc. ): 12 12 ( 5) ; 9 9 ( 5) absorbency: Sorptive capacity ( ml/m2 ) : 350 ; Sorptive rate ( Sec ): 3 ION ( ppm ) Sodium ( Na+ ): 0.5 Potassium ( K+ ) 0.5 Calcium ( Ca2+ ) 0.5 Chloride ( Cl- ) 0.5 NVR ( ppm ) : IPA extract : 500 ; DIW extract : 500 LPC ( counts/ m2 ) 0.5um 10 106 Dry flex test 0.3um ( counts/ft3 ) 12 12 500 9 9 300
27
LTK3000E
-
100% polyester continuous filament yarn. Excellent tearing strength. Highly absorbent. Standard weight. Extremely low ion content, particle generation and extractable residue. All four edges are 4mm ultrasonic sealed borders. Compatible for Class 1, 10 or 100 cleanroom.
28
LTK 2020
-
Item: Advanced & Economic
Size: 9"x9"/12"x12"
Packaging: 100pcs/bag,30bags/ctn;150pcs/bag,40bags/ctn
29
Non-woven wiper
-
Various colours include white, blue, green, yellow and pink Various sizes include A3, A4, A5, Letter and etc. Custom colours and sizes are also available Double packed for cleanliness Smooth surfaces reduce particle contamination Cellulose sourced from sustainable managed forests Complies with RoHS 2002/05 and REACH requirements Lot traceability on each case High strength and heat resistance Good toner adhesion 100% recyclable
30
Cleanroom Paper
-
Sampling swab
Cleaning swab
31
Cleanroom Swab
-
Material: PE film coated with adhesive
Size: 18"*36/18"*45/24"*36/26"*45 36"*36/36"*45
Color: Blue/White
Packaging: 30sheets/pad,10pads/box,5 boxes/carton
32
Cleanroom access mats
-
Material: stainless steel mop rod and ESD microfiber head.
The feature: The head can be rotated 360, sterilized at 121, and absorb
vapor and powder effectively.
Mop head size45x17cm/60X17cm
Mop rod: 1.3m
Packaging: 1pc/vacuum packing
33
Cleanroom Mop
-
Feature: Powder-free, comply with FDA requirement; polymer coating design;
processed by DI water; Gamma irradiation.
Length: 300mm
Size: 6.0~8.5
Packaging: 1 pair/ wallet/ Paper bag, 50 pairs/Box, 6 catton/case.
Standard: YZB/HU2411-66-2011
34
Sterile power free Latex Gloves
-
Material: 100% pure Nitrile without plasticizers. Contain no
Phthalate Esters, Silicone oil and Amide.
Length: 300mm (12")
Size: S/M/L
Surface: fingertip textured
ISO class 5/ISO class 6
Feature: laundered with 0.2micron filtered high resistivity
D.I. water and packed in certified cleanroom
enviroment.
Packing: 500pairs/carton
35
Non- Sterile Latex Gloves
-
Material: 100% pure Natural Latex without plasticizers. Contain
no Phthalate Esters, Silicone oil and Amide.
Length: 300mm (12")
Size: S/M/L
Surface: Fingertip textured
ISO class 5/ISO class 6
Feature: laundered with 0.2micron filtered high resistivity
D.I. water and packed in certified cleanroom
enviroment.
Packing: 500pairs/carton
Packing: 20*10 (200 pairs)
36
Non- Sterile Latex Gloves
-
The fabric Material: Polyester filament fiber & conductive fiber Size: S-5L
Color: Multicolor
Feature: The clothes can be sterilized at 121 . The fabric can absorb sweat well and prevent bacterium,
tiny dust and liquid effectively, and keep clean.
It still can maintain excellent performace after 100-time cleaning
and disinfection.Sizes and style can be customer-tailored.
37
100-time cleaning and sterilizing cleanroom clothes
-
38
Technical Data of Cleanroom clothes
-
The fabric Material: Polyester filament fiber & conductive fiber Size: S-3XL
Color: Multicolor
Feature: The clothes can be sterilized at 121 . The fabrics can absorb sweat well and prevent bacterium,
tiny dust, and liquid effectively, and keep clean.
39
Cleanroom clothes
-
The fabric Material: Nylon filament fiber + conductive fiber Size: S-3XL
Color: White
Feature: The underwear can be sterilized at 121 . The fabrics can absorb sweat well and prevent bacterium,
tiny dust, and liquid effectively, and keep clean.
40
Cleanroom underwear
-
Materials: the ESD fabrics and rubber.
Size: 23-26
Feature: The boots can be sterilized at 121 .
The bottom is anti-slip and anti-stab, and protect the feet from injury in workshop.
The customer can choose advanced or economic types.
41
Cleanroom boots
-
Product: QY-I100
The feature: The UV light disinfection Automatic show counting 2s-3s loading
shoe cover
The application: Cleanroom, laboratory, medical place
The capacity: PE 100pcs shoe cover
42
Shoes cover machine
-
Vertical Autoclave
Laboratory Equipment
Biochemical /Mildew
Incubator
CO2 Incubator Sealing machine
Biosafety Cabinet Drying Oven Horizontal Shaker
Incubator
Microbiological air
sampler
-
44
Cleanroom other products
-
45
Cleanroom Stainless Steel products
-
Quaternary disinfectant
Phenolic disinfectant
Isopropyl alcohol disinfectant
Hands sanitizer
Rustbuster of stainless steel surface
46
Cleanroom contamination control & Sterility
assurance products