Thermo Scientific Critical Environment Products Where clean is critical every container - every time The only thing in your container is what you add Thermo Scientific™ Clean Process Products for Critical Environments Working within a critical environment such as a clean room necessitates high quality materials and equipment since contamination can quickly spell disaster for what are typically exceedingly sensitive applications. It is therefore essential that products used in your critical environments, such as plastic bottles, vials, carboys, caps and other materials conform to standards of cleanliness necessary. USP <788> Low Particulate Containers Certified Platinum Clean HDPE Containers Ready-to-use sizes from 30mL validation vial through 33L carboys available and Applications validated to meet < 1/3 the allowable particulate limits according to USP <788>. • Bulk intermediate, etc. storage in clean room or controlled Double, heat-seal bagged and placed into twist-tied, plastic carton liners in robust, environment use double-walled cartons. Validated sterile to SAL 10-6 and endotoxins < 0.25 EU/mL. • Pharmaceutical, Bioproduction and other sensitive applications • Validated to lower than 1/3 the allowable USP <788> particulate limits • Containers and closures cleaned in proprietary HEPA filtered washing/drying equipment • Clean packaged in superior packaging in Class 10 (ISO Class 4) HEPA filtered workstations inside our Class 100 (ISO Class 5) clean room • Sterile and low endotoxin • Virgin resin materials • Other container sizes and materials to meet and exceed USP <788> requirements available as custom options by contacting your sales specialist Closure Cat. No. Description Volume Width/OD, mm (in) Height with Closure, mm (in) No. per Pk/Cs Size Material Narrow Mouth Bottles CE-E2099-0001 Narrow Mouth Bottle 30mL (1 oz) 34.3 (1.35) 61 (2.40) 20-415 Natural PP 12/72 CE-N2099-0008 Narrow Mouth Bottle 250mL (8 oz) 61 (2.40) 133 (5.22) 24-415 Natural PP 12/72 CE-N2099-0016 Narrow Mouth Bottle 500mL (16 oz) 72.6 (2.86) 170.4 (6.71) 28-415 Natural PP 12/48 CE-N2099-0032 Narrow Mouth Bottle 1L (32 oz) 91.4 (3.60) 215.9 (8.50) 38-430 Natural PP 6/24 Wide Mouth Bottles CE-N2199-0008 Wide Mouth Bottle 250mL (8 oz) 50.3 (1.98) 99.3 (3.91) 43-415 Natural PP 12/72 CE-N2199-0016 Wide Mouth Bottle 500mL (16 oz) 72.6 (1.86) 168.2 (6.62) 53-415 Natural PP 12/48 CE-N2199-0032 Wide Mouth Bottle 1L (32 oz) 91.44 (3.60) 199.2 ( 7.84) 63-415 Natural PP 6/24 Carboys CE-N2289-0020 Carboy with Integrated Handles 10L (2.6 gal) 250.2 (9.85) 389 (15.3) 83B White PP 1/6 CE-N2289-0050 Carboy with Integrated Handles 20L (5.3 gal) 284.2 (11.19) 501.7 (19.8) 83B White PP 1/4 CE-N2289-0075 Carboy with Integrated Handles 33L (8.7 gal) 381 (15.0) 546 (21.5) 83B White PP 1/1 2 Low Particle Containers Particle-certified glass containers Applications Containers are assembled to contain as few as 5 particles per milliliter ≥ 0.5 microns. • Sampling for QC, etc. Assembled with low-shedding polypropylene closures with chemically inert PTFE • Pharmaceutical and biotech use faced liners that do not contain adhesives. Both clear and amber glass products are available. • Containers and closures cleaned in proprietary HEPA filtered washing/drying equipment • Clean packaged in Class 10 HEPA filtered workstations inside our Class 100 clean room • Certified to contain as few as 5 particles/mL ≥ 0.5 microns • Containers and components to meet USP <788> and other container sizes and materials available as custom options by contacting your sales specialist Capacity Closure Closure Cat. No. Description O.D. x H, in. O.D. x H, mm Qty/Cs oz. (mL) Size (mm) Liner Amber glass wide mouth bottle with closed top polypropylene closure 130-005/LP 0.5 (15) 28-400 PTFE 1.218 x 1.984 30.93 57 (≤ 20 particles/mL at 0.5 microns) Clear glass vial with open-top closure, particulate cleaned 140-40C/LP 1.35 (40) 24-414 PTFE / Silicone Septa 1.08 x 3.74 27.5 x 95.00 90 (≤ 10 particles/mL at 0.5 microns) Amber glass Boston round bottle with open-top closure 114-060A/LP 2 (60) 20-400 PTFE / Silicone Septa 1.516 x 3.688 38.50 x93.66 24 (≤ 10 particles/mL at 0.5 microns) Amber glass packer bottle with lined closure 120-02A/LP 2 (60) 33-400 PTFE 1.75 x 3.00 44.45 x 76.20 24 (≤ 10 particles/mL at 0.5 microns) Clear glass Boston round bottle with closed top closure 114-125CT/LP 4 (125) 24-414 PTFE / Silicone 1.875 x 4.375 47.63 x 111.13 12 (≤ 5 particles/mL at 0.5 microns) Amber glass Boston round bottle with closed top closure 114-125A/LP 4 (125) 22-400 PTFE / Silicone 1.875 x 4.375 47.63 x 111.13 12 (≤ 5 particles/mL at 0.5 microns) Amber glass packer bottle with PTFE lined closure 120-04A/LP 4 (125) 38-400 PTFE 2.125 x 3.75 53.975 x 95.25 12 (≤ 10 particles/mL at 0.5 microns) Clear glass Boston round bottle with closed top closure 114-250C/LP 8 (250) 24-414 PTFE / Silicone 2.375 x 5.375 60.33 x 136.53 24 (≤ 5 particles/mL at 0.5 microns) Amber glass Boston round bottle with closed top closure 114-250A/LP 8 (250) 22-400 PTFE / Silicone 2.375 x 5.443 60.33 x 138.25 12 (≤ 5 particles/mL at 0.5 microns) Amber glass wide mouth packer bottle with closure 121-08A/LP 8 (250) 45-400 PTFE 2.563 x 4.688 65.10 x 119.075 12 (≤ 5 particles/mL at 0.5 microns) Clear glass jar, wide mouth, with closure 132-16C/LP 16 (500) 89-400 PTFE 3.578 x 3.781 90.88 x 96.04 12 (≤ 5 particles/mL at 0.5 microns) Amber glass Boston round bottle with closure 113-500A/LP 16 (500) 28-400 PTFE 3.00 x 6.625 76.20 x 168.28 12 (≤ 5 particles/mL at 0.5 microns) Amber glass wide mouth packer bottle with closure 122-16A/LP 16 (500) 53-400 PTFE 3.172 x 5.75 80.57 x 146.05 12 (≤ 5 particles/mL at 0.5 microns) Amber glass Boston round bottle with closure 112-01A/LP 32 (1000) 33-430 PTFE / Silicone 3.75 x 8.50 95.25 x 215.90 12 (≥5 particles/mL at 0.5 microns) Clear glass jar, wide mouth with closure 133-32C/LP 32 (1000) 89-400 PTFE 3.75 x 6.69 95.25 x 169.85 12 (≤ 5 particles/mL at 0.5 microns) Amber fluorinated glass jug with closure 110-80A/LP 80 (2500) 38-430 PTFE / Silicone 5.25 x 12.00 133.4 x 305 6 (≤ 10 particles/mL at 0.5 microns) Amber glass wide mouth packer bottle with closure 123-80A/LP 84 (2500) 70-400 PTFE 5.50 x 9.375 139.70 x 238.13 4 (≤ 5 particles/mL at 0.5 microns) Amber glass jug with closure 111-04A/LP 128 (4000) 38-430 PTFE / Silicone 6.25 x 13.25 158.75 x 336.55 4 (≤ 5 particles/mL at 0.5 microns) 3 Low Particle Containers Particle-certified HDPE containers Applications HDPE bottles with polypropylene closures are leak-proof and suitable for use in • Sampling for stability studies, etc. sampling packaging and may be used with combination packaging for hazardous • Pharmaceutical and biotech use shipping. Low metals bottles are double-bagged and low metals certification includes • Plastic certified to contain as few as 20 particles/mL ≥ 0.5 aluminum, calcium, copper, iron, potassium, magnesium, manganese, sodium, and microns zinc at < 10 ppb each. Capacity Closure Size Closure Cat. No. Description O.D. x H, in. O.D. x H, mm Qty/Cs oz. (mL) (mm) Liner 156-125W/N/LP HDPE Narrow mouth Nalgene bottle with closure 4 (125) 24-415 N/A 2.00 x 4.00 50.80 x 101.60 24 156-125W/N/LPM HDPE Narrow mouth Nalgene bottle with closure, low metals 4 (125) 24-415 N/A 2.00 x 4.00 50.80 x 101.60 24 157-250W/N/LP HDPE Narrow mouth Nalgene bottle with closure 8 (250) 24-415 N/A 2.50 x 5.25 63.50 x 133.35 24 150-01W/N/LP HDPE Narrow mouth Nalgene bottle with closure 32 (1000) 38-430 N/A 3.625 x 8.50 92.08 x 215.90 12 150-01W/N/LPM HDPE Narrow mouth Nalgene bottle with closure, low metals 32 (1000) 38-430 N/A 3.625 X 8.50 92.08 x 215.90 12 Processed at our ISO 9001:2008 ISO certified facility 4 Depyrogenation Depyrogenated glass Applications: Save the need to invest in expensive capital equipment with ready-to-use • Packaging and storing articles that will be terminally sterilized depyrogenated glassware in a wide variety of sizes and configurations. • Storage of laboratory reagents and medias The containers have been specially prepared to meet endotoxin levels of • Sample storage < 0.25 EU/mL. • Water sampling • To meet low endotoxin container needs for terminal sterilization or endotoxin-limited environments • Testing performed according to USP <85> • Endotoxin levels of < 0.25 EU/mL • Containers and closures cleaned in proprietary HEPA filtered washing equipment with low endotoxin water followed by 250ºC depyrogenation cycle • Clean packaged in Class 10 (ISO Class 4) HEPA filtered workstations inside our Class 100 (ISO Class 5) clean room Capacity Closure Closure Cat.