PHARMACEUTICAL &

MEDICAL CONSUMABLES

Index

1.

ATMI Ultraclean Sterile Packaging

2.

Cleanroom Products

3.

Laboratory Equipment

4.

Cleanroom Stainless Steel Products

5.

Cleanroom contamination control products & Sterility assurance

ATMI-AUSTAR
ATMI life science and Austar Ltd. established a joint venture ATMIAustar 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.

ATMI-AUSTAR Product list

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

Ultraclean PE bags
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

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

Ultraclean PE bags
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 <88>, biological reactivity test in vivo, class VI
USP <87>, biological reactivity test in vitro
USP <661>, 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)

Ultraclean PE bags
Order Information:
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

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

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

10

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

11

Ultraclean PE bags
Specification
Cleansteam Bags
specification

Size(WL)mm

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

Packaging

12

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)

13

Ultraclean Sterile LDPE Freeze-Dry Film

Specification:
Size(WLT)mm

packaging

UP1-BS-9501060100 95010600.1

30pcs/double bag; 10bags/carton

14

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

15

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

16

Intergrity 2-D Bioprocess Vessel

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

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

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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.

20

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 ultralowdensity 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.

21

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

22

Cleanroom Product list

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

MicroPolx 2750

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

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MicroPolx 2750
ORDER INFORMATION:
Product

Item Number

Size/Metric

Shts/Pk

Pks/Cs

MicroPolx 2750

MPX275.0909.10

9x9/23x23cm

100(stack)

10

25

LTK3000I

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

LTK3000E

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

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LTK 2020

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.

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Non-woven wiper

Item: Advanced & Economic

Size: 9"x9"/12"x12"
Packaging: 100pcs/bag,30bags/ctn;150pcs/bag,40bags/ctn

29

Cleanroom Paper

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

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Cleanroom Swab
Sampling swab
Cleaning swab

31

Cleanroom access mats

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 Mop
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

Sterile power free Latex Gloves

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

Non- Sterile 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

100-time cleaning and sterilizing cleanroom clothes

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.

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Technical Data of Cleanroom clothes

38

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 underwear
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 boots
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

Shoes cover machine

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

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Laboratory Equipment

Vertical Autoclave

Biochemical /Mildew
Incubator

CO2 Incubator

Sealing machine

Biosafety Cabinet

Drying Oven

Horizontal Shaker
Incubator

Microbiological air
sampler

Cleanroom other products

44

Cleanroom Stainless Steel products

45

Cleanroom contamination control & Sterility

assurance products

Quaternary disinfectant
Phenolic disinfectant
Isopropyl alcohol disinfectant
Hands sanitizer
Rustbuster of stainless steel surface

46