CAP TORQUE TEST SYSTEMS

CALIBRATION

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Cap Inspector Calibration Services and Equipment 

Calibration Definition:

"Calibration is the validation of specific measurement techniques and equipment. At the simplest level, calibration is a comparison between measurements of known magnitude or correctness made or set with one device and another measurement made in as similar a way as possible with a second device".

All test equipment should be calibrated on a regular basis. Failure to check calibration regularly in accordance with standard operating procedures and to apply corrections if necessary, will render test equipment invalid for use in production and quality control environments. Un-calibrated instruments can increase safety issues associated with the

manufacture of sub-standard goods. All Vibrac instruments are supplied with a full traceable calibration certificate.

Why is Calibration Important?

Regular calibration ensures that you’re getting the most accurate results, which can greatly improve your ROI and avoid production loss and costly recalls. We recommend calibration be performed at least every 12 months.

 
The Gold Standard Bottle: Calibration Verification Device

Gold Standard Bottle:

The Model 2212 Gold Standard Calibration Verification bottle was designed to allow the user to quickly verify the calibration and operational repeatability of Vibrac models of torque testers. This process can be carried out in 2-3 minutes. The Model 2212 Gold Standard can be configured into the shape of a device to fit into Vibrac’s standard tooling packages.  It is 

fitted with a head piece designed according to the customer’s testing requirements.  It can also be fitted with a handle for non-motorized applications. The Gold Standard bottle is constructed using high-energy permanent magnets and heavy-duty ball bearings to ensure the long- term durability of this calibration standard. Each Gold Standard bottle is labeled with an exact torque rating which can be set to a customer specification and is supplied with a certificate of calibration and traceability. The Gold Standard bottle is manufactured exclusively by Vibrac and can easily be used on torque test devices manufactured by other companies.

Gold Standard Bottle

Specifications

Gold Standard Validation Guide

Process Validation Definition
“Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and repetitively to produce a product meeting its pre-determined specifications and quality attributes.”
Validation Master Plan
The Validation Master Plan (VMP) from the Pharmaceutical
Inspection Convention covers the following 5 areas: 
1) Design Spec Qualification; 2) Installation Qualification (IQ); 3) Operational Qualification (OQ); 4) Performance Qualification(PQ); and 5) Change Control.  Vibrac’s Gold Standard Validation Guide is designed to provide the user with the necessary documentation for performing 3 of the 5 elements of the VMP as related to the Model 2100 Cap Inspector:  IQ, OQ, and PQ.  The PQ element contains all of the necessary information for performing a Gage R & R Study. 
Performing a Gage R & R (or Gage Capability) Study
The Gage Study is used to demonstrate that the Cap Inspector is capable of providing the required accuracy, repeatability and reproducibility of measurements for the required application.  Repeatability is the variability of the measurements obtained by one person while measuring the same item repeatedly.  Reproducibility is the variability of the measurement system caused by differences in operator behavior.  The Gage Study is performed by having three operators test each Gold Standard bottle 10 times and then record the data.  This data must then be typed into the computer that the supplied software has been installed on.
Other Calibration Equipment:
 
Cap Inspector Calibration Service:

Performing a Gage R & R (or Gage Capability) Study:

The Gage Study is used to demonstrate that the Cap Inspector is capable of providing the required accuracy, repeatability and reproducibility of measurements for the required application.  Repeatability is the variability of the measurements obtained by one person while measuring the same item repeatedly.  Reproducibility is the variability of the measurement system caused by differences in operator behavior.  The Gage Study is performed by having three operators test each Gold Standard bottle 10 times and record the data.  This data must then be typed into the computer that the supplied software has been installed on.

Why Should I have Vibrac Perform my Calibration?

Since we’re the ones that made your machine, we’re the best ones to calibrate it. Unlike 3rd party calibration labs that may lack familiarity with our testers, our technicians have the most intimate understanding of proper calibration techniques. This means we can ensure that your torque tester will be optimized for the best possible performance and most accurate data.

What does a Vibrac Factory Calibration Include?

During our standard calibration procedure, we calibrate the system to both clockwise and counterclockwise directions and check the linearity with 4 different torque standards. After calibrating your cap torque tester, we prepare an NIST- traceable certificate for you. Your calibration will include:

  • Thorough inspection of your cap torque analyzer

  • Make sure it meets all original specifications

  • Clean the system and the area immediately around it

  • Inspect all tooling and accessories

  • Complete all paper work and certification documents

  • Review any questions with your operator(s)