10 ml - 10R Injection vial - EtO sterile and depyrogenated Type 1 Clear glass, with Crimp neck 20 mm neck finish. Pharmaceutical grade borosilicate tubular glass. Vials packed in tray configuration, 96 pcs per polystyrene tray covered with Tyvek cover sheet. Each tray is heatsealed with a Tyvek lid and packed in a steribag. Dimensions (OD x H) 24 mm x 45 mm.
| Nominal volume |
10
|
| Brimful volume - ml |
13.5
|
| DIN ISO |
10R
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| Type of glass |
Buisglas
|
| Hydr. Class |
Type 1
|
| Colour |
Helder
|
| Type |
EZ-fill
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| Diameter (od) - mm |
24
|
| Height (h1) - mm |
45
|
| Neck finish |
Felskraag 20 mm
|
| Package |
Tray
|
- Each phase of the EZ-fill™ production process is conducted in sophisticated cGMP facilities equipped with the latest generation equipment within certified cleanrooms [ ISO 8 (class 100,000), ISO 7 (class 10,000), ISO 5 (class 100)] using validated processes that are constantly monitored and controlled in well-equipped laboratories, performed by well-trained staff.
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- The EZ-fill™ glass containers are washed only with water for injection and dried with air, filtered through a 0.22 micron sterilizing filter.
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- EZ-fill™ Vials available in 2R, 4R, 6R, 8R and 10R
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- EZ-fill™ vials are available in tray and nest packages.
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- EZ-fill™ vials will be sealed with a Tyvek™ sheet, package in Tyvek™/plastic steribags and case-pack allowing for sterilization with ethylene oxide.
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- EZ-fill™ tray, nest, Tyvek™ liner and Tyvek™/plastic steribag are all produced under ISO level 7 conditions.
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- EZ-fill™ vial production by OMPI, obtained the certification ISO 15378:2006 on primary packaging materials for medicinal products.
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- EZ-fill™ Vials, a new standard and scalable solution for clean and sterile pharmaceutical glass containers ready to be filled
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- EZ fill™ Vials provide pharmaceutical companies with a clean, sterile, pyrogen-free glass container, ready to be filled.
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- EZ fill™ Vials facilitates tech transfer, eases issues of site to site transfer of production, ideal for work with CMO's.
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- EZ fill™ Vials reduce processing and validation costs
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- EZ fill™ Vials reduce time to market and increase flexibility.
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