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PTI OptiPac

PTI OptiPac

Beschreibung

OptiPac

Blister packaging is one of the most practical and convenient packaging formats for tablets and capsules. Blister packaging is specifically used for tablets and capsules to pack them in a convenient and controlled way for easy patient use.

Blister packaging is designed for long and tamper-proof shelf life by eliminating moisture ingress and contamination. In today’s drug delivery systems where certain drugs are extremely sensitive to moisture and Oxygen, it is critical to ensure the package integrity of blister packs to ensure that product quality is not compromised.

Vacuum decay is a non-destructive container closure integrity testing method for blister packaging. PTI offers two technologies for integrity testing of multi-cavity blister packaging.

OptiPac One-touch Tool-less Blister Package Leak Testing

Non-destructive package testing of multi-cavity blisters

The OptiPac One-Touch Tool-less Leak Detection System is a deterministic non-destructive technology designed specifically for multi-cavity blister packs. OptiPac utilizes volumetric imaging under vacuum with topographic imaging to detect the presence and location of leaks. The ptiPac is engineered and designed with One-Touch Technology to achieve a rapid test cycle requiring no changeover or sample preparation. Operators simply place the blister package on the test plate and press the START button. Blister packs can also be placed in any orientation or position. Within seconds, the operator sees a definitive pass/fail result, and a visual identification of blister cavity defects. OptiPac technology is unique in that it can provide rapid detection of sub-5-micron defects depending on blister cavity volume. OptiPac requires no tools for different blister formats.

OptiPac Benefits

  • Non-destructive technology – Pass/Fail results backed by quantitative test data
  • Completely tool-less
  • No changeover to test different blister formats
  • Identifies defective cavity
  • Pre-loaded recipe library with easy recipe setup and validation of new blister formats

Inspection Criteria

  • Leak detection and seal integrity testing of entire package
  • Test sensitivity down to 5 microns

Specifications

Application

Non-destructive leak detection of blister packs (ranging from 1 cavity up to multi-cavity blister packs)

Package Type / Materials

• Blister packs/foil, paper, aluminum
• Cold form and thermo formed blister packs

Technology

Volumetric imaging under vacuum

Offline or OnlineOffline inspection station
Operator Interface

Integrated Windows 10 Computer – 15.6” Wide Touch Screen HMI
• Option to connect external keyboard and mouse

Test Result Data

Pass/Fail result on touch screen and measurement reading

Data Collection

• View on HMI screen
• PTI-ETHOS CFR 21 Part 11 Software

– Windows 10 Active Directory Management or local using SQL Server

• USB stick for easy data transfer

Test Sensitivity

• <5 Microns

Test Chamber

Integrated test chamber

Test Instrument Enclosure

Stainless steel compact frame houses PLC controller, operator touch screen display and internal vacuum generator

Dimensions/Weight

17.3”W X 19” D X 53.2” H | 80 lbs.

Power

100-240 VAC, 50/60 Hz, 2.0A

Air Supply

90 psi

Options

Validation Qualification Package (IQ/OQ)