Specification of Clear Mould glass vials (20 ml)
This article describes the Packing material specification of Clear Mould glass vials (20 ml). Which is used pack the Dry powder for injection Powder.
Specification for Clear Mould glass vials (20 ml).
I. Product Information for Clear Mould glass vials (20 ml) :
| Art Work Number : | NA |
| Supplier / Manufacturer : | As per approved vendor list |
| Sampling Procedure: | Sampling to be performed as per current version of SOP |
| Sample Quantity : | 10 Vials |
| Item Code : | As per SOP number |
| Testing procedure: | Testing to be performed as per respective STP |
| Storage Condition: | Controlled Room temperature |
| Sampling and Handling Precautions
(If Any): |
Use personal protective equipment’s while handling the material. |
II. Specification for Clear Mould glass vials (20 ml) :
| Sr. No. | Test | Specification | Reference |
| 1. | Description * | Clear glass vials no any foreign matter inside the glass vials. | IH |
| 2.
|
Physical Dimension | ||
| A. Total Height | 57.50 mm ± 0.5 mm |
IH
|
|
| B. Outside Diameter of body | 32.00 mm ± 0.40 mm | ||
| C. Thickness of Bottom | 3.00 mm ± 1.20 mm | ||
| D. Weight of Glass vials | 28.0 gm ± 2 gm | ||
| E. Overflow capacity | 27.00 ml ± 1.5 mL | ||
| 3. | Chemical Test | ||
| A. Hydrolytic resistance | The result of titration is not greater than the 8.1 ml | IP | |
| B. Arsenic * | The absorbance of the test solution does not exceed the absorbance obtained by 0.1 ml of arsenic standard 10 ppm. | ||
Remark: * Test to be carried out for Retesting of Packing Material.
III: Revision History for Clear Mould glass vials (20 ml):
| Version No. | Reason for Revision | Change Control No. | Effective Date |
