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Sterile Glass Cartridge in Nest&Tub

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Product name：
Sterile Glass Cartridge in Nest&Tub

Category
Product category：Glass Cartridge
All FAMACY Cartridges are manufactured in environmentally controlled areas certified by ISO 9001. Washed and packed in clean room comply with PH.Eur., USP and JP international standards.
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Number of views:
1000
Product serial number
800,000 pcs per day
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Detailed introduction
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Product Details:

Produced from Type I glass tubing supplied by leading European glass s manufacturer.

● Production in cGMP environment

● Internal Siliconized

● Statistical in-process control

● Dimensional and cosmetic AQL levels according to ISO

● 100 % camera inspection

 

Quality Specification:

Component Material Description Regulatory Reference
Cartridge Glass body: Type：highly resistant borosilicate tubing glass (Type I)

Design: ISO 13926-1

Glass Container: USP<660>
Internal Lubrication: Silicone Dow Corning 360

Silicone oil used as lubricant:EP 3.1.8

Dimethicone:USP29-NF24*

Amount of silicone: EP 3.2.8*

RTU Sterile

Packaging materials:

Nest: Polypropylene

Tube:Polystyrene

Tyvek inlay & Tyvek seal

Outer bag: Sterile bags

 Polymers according to USP<88> classVI*
Sterilization: ≤50nm/mm ISO 11135

 

 

Size Specification:

a
d1 tol.
±		 d2 tol.
±		 d3
min.		 d4 tol.
±		 d5 tol.
±		 d6 tol.
±		 h1 tol.
±		 h2 tol.
±
8.65 0.1 6.85 0.1 6.55 7.15 0.2 5.5 0.35 3.15 0.2 5.0 0.20 2.9 0.1
10.85 0.1 8.65 0.1 8.35 7.15 0.2 5.5 0.35 3.15 0.2 5.0 0.20 2.9 0.1
10.95 0.15 9.25 0.1 8.95 7.15 0.2 5.5 0.35 3.15 0.2 5.0 0.20 2.9 0.1
11.60 0.15 9.65 0.1 9.35 7.15 0.2 5.5 0.35 3.15 0.2 5.0 0.20 2.9 0.1
14.00 0.15 12.00 0.15 11.65 95 0.2 7.6 0.35 4.5 0.2 5.0 0.50 2.9 0.15
14.45 0.15 11.85 0.15 11.50 95 0.2 7.6 0.35 4.5 0.2 5.0 0.50 2.9 0.15
18.25 0.1S 16.05 0.15 15.50 95 0.2 7.6 0.35 4.5 0.2 5.0 0.50 2.9 0.15

 

 

Sterile cartridges in Nest&tub Packaging and Sterile Bags:

a

 

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