Penetrability Tester
The rubber stopper penetrability test under USP <382> is crucial for ensuring the functional suitability of elastomeric closures in injectable pharmaceutical packaging. This test evaluates how easily a needle or spike can pierce the stopper while maintaining integrity.
Significance of the Test:
- Ensures Safe Drug Access: Confirms that healthcare professionals can reliably puncture the stopper without excessive force.
- Prevents Fragmentation: Reduces the risk of rubber particles contaminating the drug product.
- Maintains Sterility: Assesses the stopper’s ability to self-seal after penetration, preventing microbial ingress.
- Compliance with Regulatory Standards: Helps pharmaceutical manufacturers meet USP <382> requirements for container closure integrity.
This test is essential for ensuring consistent performance in drug packaging systems, particularly for vials and syringes.
Confirms to : USP 381 / USP 382 / ISO 8871
Lead Time : 4-6 weeks
Penetrability Tester for Vial Rubber Stoppers
An equipment to test the penetration force of rubber stoppers used in pharmaceutical vials.
Technical Specifications :
- Digital Model with Backlit LCD Display
- Computer Controlled with facility to capture test data on to the PC directly through the software and generate PDF test & calibration reports.
- Motorised operation with Ball screw mechanism for extra smooth operation.
- Variable Speed control with Stepper Drive
- Test Speed : 10-500 mm/min. (User Selectable)
| Model : | PT10 |
| Capacity : | 10,000gm (~100N) |
| Resolution : | 1 gm (0.01N) |
| Accuracy : | 0.2% F.S. (20 gm or 0.2N) |
Included with all models / SKUs :
- Syringe Holder (to fix standard syringe 2ml) x 1 nos
- Vial Holder (for each vial diameter) x 3 nos
- Extra Vial Holders can be purchased.
- Starter set of 100 needles (0.8mm / 21G) x 1 set
- Extra Set of needles can be purchased from us or any hospital supplies vendor.
- RS-232 Data Cable with USB-Serial Convertor 1 set
- DQ/IQ/OQ Documentation are supplied with the equipment.
Excluded :
- None
Software : 21-CFR-11 Compliant Software (Vantage).
Click here for detailed feature comparison of Regular vs 21-CFR-11 Compliant Software
Utilities Required :
- Power Supply (Current : Max 5 Amps) :
- For India (Domestic Model) : 230 Volts A.C., 50 Hz. Clean power.
- For Outside India (Export Model) : As per your country’s power rating.
- Calibration weights : 3 Kg (0.5 + 0.5 + 1 + 1 Kg)
- Desktop / Laptop PC (Intel Core i3, 4gb RAM, Win10 OS, 1080p Monitor) or higher.
Warranty : 12 Months (Back-to-Bench)
Terms and Conditions
Delivery / Freight Charges
Prices (if mentioned) on our website DO NOT INCLUDE Delivery / Freight Charges.
Domestic (India) customers will have the option of Freight To-Pay / Freight Prepaid.
Export (Outside - India) customer will have the option of Freight Prepaid or their can collect on their own Courier Account with UPS / DHL / FEDEX, etc.
If you want Freight Prepaid, let us know after receiving the quotation. We will add delivery charges and resend the offer.
Product Lead Time
Lead Time mentioned in the description is a tentative timeline for us to dispatch the product. Please consider additional days for transit period by courier / freight agency. This timeline is on "Best Effort" basis.
Sometimes there can be a delay due to unforseen circumstances beyond our normal control. Delays if any will be intimated to you at the time of ordering.
Product Warranty
Unless otherwise specified in the description, all products and accessories (excluding consumables and spares) manufactured / sold by us are covered under a standard 12 month warranty period.
The warranty is "Ex-Factory" or "Back-to-Bench", meaning the product or defective part will have to be sent back to us for repair or replacement. To and Fro Freight / Courier charges are to be borne by the buyer. The warranty only covers manufacturing defects and not misuse or any other damages.