The Tensile Strength Tester with 21 CFR is one of the most used instruments in the packaging industry. The tensile tester helps in calculating the tensile force which acts on the specimen. During the test the specimen is placed between the clamps. The clamps are then separated automatically. Due to the separation, the force applied on the specimen leads to destruction. The Testronix Tensile Strength instrument hence records the peak value at which the destruction took place and displays it on the digital display. This instrument offers highly accurate values to the users. This makes the instrument user friendly and adaptable
Various standards are adhered to which are as follows: ASTM D412, ASTM D429-73, ASTM D624, ASTM D638-01, ASTM D76, IS 13360-5-7, IS-3400.
The Tensile Strength Tester with 21 CFR helps ensure materials used in packaging, production and product development remain strong, reliable and consistent by checking how well they handle stretching or pulling forces during real-world use. This software maintains a consistent method of TSP, enhancing production reliability by providing quick and accurate data. It enables the production team to detect issues earlier, reduce product returns and ensure compliance with industry standards and regulations.
This software allows you to easily identify how well your packaging films, foils, or seals withstand use and transportation within minutes of testing. It has helped improve the way companies manufacture products by pointing the way to areas where changes need to be made so as to improve the quality of their products. With simple operation and dependable performance, it fits well into both routine inspections and detailed testing, giving manufacturers confidence that their materials meet safety standards.
Applications
Testing the strength of packaging films and foils.
Checking seal integrity on pouches and sachets.
Evaluating tensile properties of medical device materials.
Assessing the durability of pharmaceutical blister packs.
Comparing material performance in R&D and formulation work.
Verifying compliance with regulatory packaging standards.
Monitoring consistency of raw materials during production.
Testronix Instruments is leading manufacturer and supplier of Tensile Strength Tester with 21CFR in India. To get the best price, request a quote or call us now!
Advanced load sensor sensing through advanced electronics.
Elongation Calibration Facility?
Smart Logical Control System?
Branded Load Cell (Reputed Make)
Highly sensitive load sensor
Speed Drive In built - Variable Speed Drive (optional)
Rugged and robust body
Safety limit switches for over travel safety
Overload protection Faclity?
Highly accurate micro-controller based system controls
Peak Hold facility available
Precise elongation feature
Powder coated corrosion resistant structure
Ergonomically designed structure
Single column rugged structure
Part Compliance to 21CFR Part 11?
1. Access Control & User Management
Role-based user accounts (Operator, Supervisor, Administrator).
Unique user ID and password required for login.
Automatic logout after inactivity.
Password policies configurable as per organizational SOPs.
2. Audit Trail (Non-erasable, Computer-Generated)
Every action (test start, test stop, parameter editing, report generation, data export, login/logout) is automatically logged.
Audit trail includes:
User name
Action performed
Old value vs new value
Date and time
Audit trail cannot be modified or deleted.
3. Electronic Signatures
Supports multi-level electronic signatures as per Part 11 Subpart C:
Test Performed By
Reviewed By
Approved By
Each signature includes:
Printed name
Date & time executed
Meaning of signature (Approval / Review / Creation)
4. Data Integrity & Security
Encrypted data storage.
Protection against unauthorized data modification.
Automatic backup and database protection available.
Test results cannot be overwritten; new entries are created for every run.
Software ensures ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
5. Report Generation & Export Controls
Reports can be generated in PDF, Excel, or secure proprietary formats.
Export rights are controlled by admin privilege.
Each report contains unique identification and time stamps.
Accuracy - ±0.5% of Load Cell Capacity
Load Capacity 50kgf
Travel length of the grips-??750mm.
Motor – 1/5 HP, – 1440 rpm, 1 phase power supply.
Grip to grip separation: Min 25mm and max 700mm
Capacities available- (Select 1 capacity)
|
Capacities (Kg.)???? Least Count |
|
5???????????????????????????? 1gm |
|
10?????????????????????????? 1gm |
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20?????????????????????????? 2gm |
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50?????????????????????????? 5gm |
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100?????? ?????????????????10gm |
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250? ? ? ? ? ? ? ? ? ? ? ? 50gm |
Types of grips (optional and additional):
Flexural
Compression
Plate Wedge Type
Roller Type
Vice grips
Self Tightening Grips
Zig Zag?
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