Sankeen Industrial Co., Ltd.

Sankeen Industrial Co., Ltd.


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Contact Us

Tel: 0086-531-85018768
Fax: 0086-531-87906658
E-mail: info@skvial.com
Add: No.662 Hualong Road, Jinan China
MSN: skvial@hotmail.com
Skype: skvial
MSN: skvial@hotmail.com SKYPE: skvial

Technical Support

 Pharmaceutical Glass Technical Information

Terminology

Borosilicate-
A glass that is high in silicate and having at least 5% boron oxide.3.3, 5.0 and 7.0
Linear Coefficient of Expansion-Fractional change in length of glass per degree change in temperature.
Strain Point- Maximum temperature to which glass should be heated during use.

Type of Glass-CH.P, EP, JP, USP, etc. Take USP Type as an example.

USP Type-Pharmaceutical glass containers can be classified as USP Type I, II, III
Type I-Borosilicate glass represents the least reactive glass.
Type I glass has the least pH shift. (Lowest leaching characteristics
)
Coefficient of Expansion = 33 or 50 or 70
Type II - is de-alkalized soda lime glass with higher levels of sodium hydroxide and calcium oxide.
Type III - soda lime glass - cannot be autoclaved.
Coefficient of Expansion = 90

Process of Butyl Rubber Stopper

Raw materials mixing in the 100000 level cleanroom-Compounding in the 10000 level cleanroom -Curing in 300000 level cleanroom-Trimming in the 100000 level cleanroom-Precleaning in the 100000 level cleanroom-Washing in the 10000 cleanroom-Packaging & Storing in the 100 level cleanroom

 Quality standards for air cleanliness

Cleanroom Level
The maximum allowable
number of particles/m3
The maximum allowable number of microorganisms
≥0.5um
≥5um
Settlement of bacteria/vessel
100 level
3500
0
1
10000 level
350000
2000
3
100000 level
350000
20000
10
300000 level
10500000
60000
30

Process of Aluminum Cap and Flip off Cap

Aluminum Cap:Stamping- Cleaning-Testing-Packaging

Flip off Cap
: Plastic sheet molding- Stamping of aluminum cap -CleaningTesting-Assembling-Packaging

Terminology

Coating: the process of aluminum sheet, including single coated and double-side coated, in order to prevent the oxidation of aluminum cap.
Polishing: By chemical polishing or electrochemical polish, it can make the aluminum caps looks more smooth and brighter.

Note: the coating and polishing are only for aluminum caps.

Download Files:
COA of Ampoule
COA of Molded Vial
COA of Rubber Stopper
COA of Test Tube
COA of Tubular Vial
COA of Vial Cap
Drawings of Test Tube
Drawings of Ampoule
Drawings of Molded Vial for Injection and Infusion
Drawings of Tubular Vial
Drawings of Vial Cap
Drawings or Rubber Stopper

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