Sepha Ltd.

25, Carrowreagh Business Park, Carrowreagh Rd., Dundonald, BT16 1QQ Belfast
United Kingdom of Great Britain and Northern Ireland

Telephone +44 2890 484848
Fax +44 2890 480890
info@tasitest.com

This company is co-exhibitor of
TASITEST Packaging Test & Inspection

Hall map

interpack 2017 hall map (Hall 16): stand F23

Fairground map

interpack 2017 fairground map: Hall 16

Our range of products

Product categories

  • 01  Packaging machines and devices
  • 01.05  Inspection and control
  • 01.05.02  Leackage test systems/devices

Leackage test systems/devices

Our products

Product category: Leackage test systems/devices

VACUUM DECAY METHOD

Vacuum Decay Method (VDM) is a non-destructive Container Closure Integrity (CCI) testing practice applicable to most pharmaceutical package systems.
Bonfiglioli Engineering developed the VDM system in accordance with the ASTM approved test method F2338 that is recognized by Food and Drug Administration (FDA) as a consensus standard for pharmaceutical packages integrity.
CCI testing is performed while the package itself is held within an hermetically sealed test chamber.
In the presence of failure in the package closure integrity (leakage) as a consequence of the application of vacuum within the test chamber and hence of a differential pressure between the inside and the outside of the package the air moves from the high pressure zone (within the package) to the low pressure zone (outside the package) causing a progressive pressure rise (that is a vacuum decay) outside the package.
Vacuum decay can also result from the volatilization of packaged liquid that partially or fully occludes the leak path.
In this case vacuum decay will occur if the chamber test pressure is lowered below the liquidandrsquo s vaporization pressure.
A vacuum decay greater than a given threshold at end of the testing phase points out a leakage.
Once the test chamber is loaded with the package to be tested and hermetically closed the VDM process comprises the following phases
  • Vacuuming the period of vacuum setting within the test chamber
  • Stabilization the time necessary to get a homogeneous vacuum distribution within the test chamber
  • Testing the time frame in which the vacuum level is monitored by means of a dedicated transducer two measurements are taken respectively at the beginning (1st reading) and at the end (2nd reading) of this phase.
Following the testing phase the VDM decision-making is performed by means of comparing the vacuum decay DELTA andldquo andDelta andrdquo (andDelta = 1st - 2nd reading) to a predetermined threshold THR

if andDelta andle THR the PFS is classified as conforming (no detectable leakages)
if andDelta > THR the PFS is classified as defective (a micro leakage is detected)
In case that a preset minimum level of vacuum (M_LEV) is not reached at 1st reading time the package is classified as defective as well (a large leakage is detected)

NEW FEATURE AVAILABLE
When dealing with prefilled syringes the system is equipped with an unique technical solution preventing the plunger movement during Vacuum Decay testing phase.

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Product category: Leackage test systems/devices

PRESSURE DECAY METHOD

Pressure Decay Method (PDM) is a non-destructive Container Closure Integrity (CCI) testing practice applicable to most pharmaceutical package systems.
PDM is usually the preferred approach when dealing with oil-based products (high viscosity or density).

CCI testing is performed while the package itself is held within an hermetically sealed test chamber.
In the presence of failure in the package closure integrity (leakage) as a consequence of the application of pressure within the test chamber and hence of a differential pressure between the inside and the outside of the package the air moves from the high pressure zone (outside the package) to the low pressure zone (within the package) causing a progressive pressure drop (that is a pressure decay) outside the package.
A pressure decay greater than a given threshold at end of the testing phase points out a leakage.

Once the test chamber is loaded with the package to be tested and hermetically closed the PDM process comprises the following phases
  • Pressurizing the period of pressure setting within the test chamber
  • Stabilization the time necessary to get a homogeneous pressure distribution within the test chamber
  • Testing the time frame in which the pressure level is monitored by means of a dedicated transducer two measurements are taken respectively at the beginning (1st reading) and at the end (2nd reading) of this phase.
Following the testing phase the PDM decision-making is performed by means of comparing the pressure decay DELTA andldquo andDelta andrdquo (andDelta = 1st - 2nd reading) to a predetermined threshold THR

if andDelta andle THR the PFS is classified as conforming (no detectable leakages)
if andDelta > THR the PFS is classified as defective (a micro leakage is detected)
In case that a preset minimum level of pressure (M_LEV) is not reached at 1st reading time the package is classified as defective as well (a large leakage is detected)

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About us

Company details

As a part of the new TASITEST platform, Sepha represents the product line which incorporates unique, innovative and patented technologies to help meet the requirements of our demanding client base throughout the world including many of the top global pharmaceutical manufacturers.

Tasitest Sepha product line is chosen for its ability to improve quality assurance procedures and to reduce manufacturing costs, enabling clients to efficiently meet the stringent regulatory requirements of the industry.

Tasitest Sepha product line incorporates 3 main divisions

  • Packaging Solutions
  • Product Integrity Testing
  • Product Recovery
Sepha products are also adaptable for other industries, there is always scope for customisation. The engineering team are continually developing and reviewing the technologies in context to ensure that they are providing the optimum solutions for clients.

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Company data

Target groups

Pharmaceuticals