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 media • Filters • Medical devices • Cleanroom garments • Syringe components • Organs 5 .Medical powders • Vials and containers • buffers.Ultraclean PE bags Application: For packaging and /or gamma sterilization of : • stoppers. caps and closures • API. 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 6 . plastic containers and closures for pharmaceutical use LDPE film is Animal Derived Component Free (ADCF) 7 . physicochemical test – plastics EP monograph 3. biological reactivity test in vitro USP <661>. Polyolefins EP monograph 3.2. class VI USP <87>.Ultraclean PE bags LDPE film is compliant to: • • • • • • • • • FDA Title 21 Code of Federal Regulation 177.1.1520 ‘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>.3.4. Polyethylene without additives for containers for parenteral and ophthalmic preparation EP monograph 3.2.1. biological reactivity test in vivo. 1 30pcs/double bag.180pcs/carton 8 .Ultraclean PE bags Order Information: specification size(W×L×T)m packaging PEF-BS-550×750×100 550×750×0.1 50pcs/double bag.300pcs/carton PEF-BS-1000×1200×100 1000×1200×0. caps and closures • vials and containers • syringe components • stainless steel lab or process equipment • Medical devices • Cleanroom garments 9 . Gamma irradiation Sterilization of : • stoppers. EO.Tyvek & HDPE bags/Roll Application For Steam. 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 Benifits • • • • • • Ultra pure & clean bag with low particle. 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(W×L)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 . labor cost and. certified) 13 . production time. energy cost.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. Pre-sterilized bags available upon request (gamma irradiated at 25 kGy. 1 30pcs/double bag.Ultraclean Sterile LDPE Freeze-Dry Film Specification: Size(W×L×T)mm packaging UP1-BS-950×1060×100 950×1060×0. 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. Applications include contained transfer. storage or shipping of: Dry powder media • Filter aids • Buffer salts • Excipients Rubber Stoppers • Flip caps 15 . from research to high-volume manufacturing. 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(α β valve) and other third-party containment devices Small size for ease of storage 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. 17 . 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.Intergrity 2-D Bioprocess Vessel • Efficient movement and storage of liquids is critical to modern biotechnology processes. 18 .Intergrity 2-D Bioprocess Vessel • At the heart of ATMI’s 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. strength and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements. then laminated to create a gas barrier film of exceptional cleanliness. 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 ATMI’s advanced whole-bag testing technology “Universal” TK8 bioprocess film 19 . 20 . scalable single-use liquid storage containers that are compatible with ATMI’s market-leading range of single-use mixing and bioreactor technologies.Intergrity 3-D Bioprocess Vessel • ATMI’s Integrity™ 3-D Bioprocess Vessel (BPV) products have been developed to meet the demand for cost-effective. 21 . strength and clarity that is animal derived component free (ADCF) and complies fully with USP Class VI requirements. The product-contacting layer of TK8 film is blow extruded in-house by ATMI under cleanroom conditions using medical-grade ultralowdensity polyethylene resin.Intergrity 3-D Bioprocess Vessel • At the heart of ATMI’s Integrity systems and products is Integrity TK8 film. then laminated to create a gas barrier film of exceptional cleanliness. a state-of-theart multi-layer gas-barrier polymer laminate. “Universal” TK8 bioprocess film 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 ATMI’s advanced whole-bag testing technology. 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 • • • • • • • • • Wipers: Microfiber wiper: MicroPolx™ 2750 Wide sealing microfiber wiper Sealed-edge microfiber wiper Polyeaster wiper: LTK3000I. Works well with IPA and other solvents Excellent absorption with de-ionize water and oils. 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 . polishing & buffing paintwork. degreasing. Smooth texture is ideal for cleaning delicate part. pre-cleaning.MicroPolx™ 2750 • • • • • • • • • • Recommended for using in ISO Class 4-5 (Class 10-100) Cleanroom. 0909.10 9x9”/23x23cm 100(stack) 10 25 .MicroPolx™ 2750 ORDER INFORMATION: Product Item Number Size/Metric Shts/Pk Pks/Cs MicroPolx 2750 MPX275. ) ≤ 0. Sorptive rate ( Sec ) : 3 ION ( ppm ): Sodium ( Na+ ) ≤ 0. 26 .5um ≤ 10 × 106 Dry flex test ≥0. Potassium ( K+ ) ≤ 0.LTK3000I • • • • • • • • • • Material: Polyester and nylon blended micro denier continuous filament yarn Cutting method: Sealed cut Basic weight ( g/ m2 ) 175 ± 5 Size ( Inc.5 . Chloride ( Cl.5 .3um ( counts/ft3 ) 9 × 9 ＜ 300 . Calcium ( Ca2+ ) ≤ 0. ): 12 × 12 ( ± 5﹪) .5 . 9 × 9 ( ± 5﹪) Absorbency : Sorptive capacity ( ml/m2 ) : 330 .5 NVR ( ppm ) : IPA extract ≤ 500 . 9 × 9 100 Pcs/Bag 10 Bags/Ctn. 12 × 12 ＜ 500 Package 12 × 12 100 Pcs/Bag 10 Bags/Ctn. DIW extract ≤ 500 LPC ( counts/ m2 ) ≥0. 3um ( counts/ft3 ) 12 × 12 ＜ 500 9 × 9 ＜ 300 27 .5 Chloride ( Cl.LTK3000E • • • • • • • • • Material: Polyester and nylon blended micro denier continuous filament yarn Cutting method: Sealed cut Basic weight ( g/ m2 ) : 225 ± 10 Size ( Inc. DIW extract : ≤ 500 LPC ( counts/ m2 ) ≥0. Sorptive rate ( Sec ): 3 ION ( ppm ) Sodium ( Na+ ): ≤ 0. 9 × 9 ( ± 5﹪) absorbency: Sorptive capacity ( ml/m2 ) : 350 .5 Potassium ( K+ ) ≤ 0.5 NVR ( ppm ) : IPA extract : ≤ 500 .5 Calcium ( Ca2+ ) ≤ 0. ): 12 × 12 ( ± 5﹪) .) ≤ 0.5um ≤ 10 × 106 Dry flex test ≥0. Extremely low ion content. 10 or 100 cleanroom. Standard weight. Compatible for Class 1. All four edges are 4mm ultrasonic sealed borders. Excellent tearing strength. particle generation and extractable residue. Highly absorbent. 28 .LTK 2020 • • • • • • • 100% polyester continuous filament yarn. Non-woven wiper • • • Item: Advanced & Economic Size: 9"x9"/12"x12" Packaging: 100pcs/bag.30bags/ctn.40bags/ctn 29 .150pcs/bag. yellow and pink Various sizes include A3. A5. green. blue.Cleanroom Paper • • • • • • • • • • • Various colours include white. 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 . A4. Letter and etc. Cleanroom Swab • Sampling swab • Cleaning swab 31 . 10pads/box.5 boxes/carton 32 .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. 3m Packaging: 1pc/vacuum packing 33 . Mop head size：45x17cm/60X17cm Mop rod: 1. and absorb vapor and powder effectively.Cleanroom Mop Material: stainless steel mop rod and ESD microfiber head. The feature: The head can be rotated 360°. sterilized at 121℃. Standard: YZB/HU2411-66-2011 34 .Sterile power free Latex Gloves Feature: Powder-free. 50 pairs/Box. Length: 300mm Size: 6. comply with FDA requirement.0~8. processed by DI water. Gamma irradiation. polymer coating design.5 Packaging: 1 pair/ wallet/ Paper bag. 6 catton/case. Sterile Latex Gloves Material: 100% pure Nitrile without plasticizers. Contain no Phthalate Esters. Packing: 500pairs/carton 35 . water and packed in certified cleanroom enviroment. Length: 300mm (12") Size: S/M/L Surface: fingertip textured ISO class 5/ISO class 6 Feature: laundered with 0.Non. Silicone oil and Amide.2micron filtered high resistivity D.I. 2micron filtered high resistivity D.Sterile Latex Gloves Material: 100% pure Natural Latex without plasticizers.I. water and packed in certified cleanroom enviroment. Contain no Phthalate Esters. Silicone oil and Amide.Non. Length: 300mm (12") Size: S/M/L Surface: Fingertip textured ISO class 5/ISO class 6 Feature: laundered with 0. Packing: 500pairs/carton Packing: 20*10 (200 pairs) 36 . Sizes and style can be customer-tailored. and keep clean.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 ℃. It still can maintain excellent performace after 100-time cleaning and disinfection. tiny dust and liquid effectively. The fabric can absorb sweat well and prevent bacterium. 37 . Technical Data of Cleanroom clothes 38 . and liquid effectively. and keep clean. The fabrics can absorb sweat well and prevent bacterium. 39 .Cleanroom clothes The fabric Material: Polyester filament fiber & conductive fiber Size: S-3XL Color: Multicolor Feature: The clothes can be sterilized at 121 ℃. tiny dust. tiny dust. and keep clean. The fabrics can absorb sweat well and prevent bacterium.Cleanroom underwear The fabric Material: Nylon filament fiber + conductive fiber Size: S-3XL Color: White Feature: The underwear can be sterilized at 121 ℃. 40 . and liquid effectively. The bottom is anti-slip and anti-stab. 41 . The customer can choose advanced or economic types. Size: 23-26 Feature: The boots can be sterilized at 121 ℃.Cleanroom boots Materials: the ESD fabrics and rubber. and protect the feet from injury in workshop. laboratory.Shoes cover machine Product: QY-I100 The feature: The UV light disinfection Automatic show counting 2s-3s loading shoe cover The application: Cleanroom. medical place The capacity: PE 100pcs shoe cover 42 . 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 .
Report "BAJU STERIL Austar Pharmaceutical & Medical Consumables-20140324"