Pharmaceutical Industry

Many pharmaceutical products with active ingredients in aqueous dissolution have a limited shelf life. They decompose by hydrolysis over a period of weeks, days, sometimes even hours. For injection or infusion dilutions, this represents a problem. A proven solution provides freeze-drying.

The main purpose of freeze-drying is to obtain storable, stable and unchanged ingredients after reconstitution. In addition to main and secondary drying the primary packaging is essential. For this purpose glass vials are used, which are sealed under vacuum.

 

In order to test the quality of each individual vial, a non-destructive detection of this partial vacuum is necessary at a high throughput rate.

The GNT PASS process provides high test reliability at a clock rate of up to 10 vials per second.

For the first time, GNT systems with PASS technology offer information beyond a good/non-good test by capturing and recording quantitative pressure values. Trends in production quality are identified and process fluctuations can be compensated in good time.

This makes 100% quality control possible – at the end of the production line or packaging process. Hence, a continuous control of the vacuum and a monitoring of the predefined negative pressure inside the vessels can be assured.

Spot test: OQC/IQC

Intensive control of the production process will not identify deterioration or a total loss of the vacuum during storage caused by fine leakages or transport damage.

In addition to the 100% testing at the and of the production, it is recommended to verify the leak tightness again before shipment (Outgoing Quality Control, OQC) by applying a spot test. A simple „good/no good“ test can be easily performed with GNT PG10 or PG100.

GNT offers the appropriate solutions for simple visual inspection as well as for quantitatively measuring spot tests.

 

Place of Use

Whether in laboratory use, integrated in production processes or final OQC, GNT´s solutions reliably and cost-effectively serve the analysis, optimization and quality assurance in the pharmaceutical industry.

 

The picture shows a typical arrangement for the testing of vials in the pharmaceutical industry. The electrode of the plasma generator is positioned on the surface of the vial. A ground electrode is used to define the path of the plasma. The optical fiber captures the plasma and feeds it to the PASS evaluation system.

High test reliability, minimal product stress and non-destructive quality control at high throughput rates combined with cost-effectiveness are essential for GNT to optimally support our customers.

Vaccum Verification

Construction of a vial test cell

A GNT vacuum test system can be easily integrated in a standard star wheel transportation system. A typical automatic high volume test arrangement comprises the following functional elements:

  • Vial Entry section: The vials (for example, coming from the rimming machine) are fed into a reservoir area.
  • Transportation star wheel: The star is adapted to the format of the vials and provides the vials at defined intervals for testing. The star is operated in steps.
  • Inspection point: At this position, the vacuum test is carried out: HV Probe and optical fiber are arranged to ensure proper feeding and detection of the plasma.
  • negative outlet: Separation of failed products.
  • positive outlet: Good tested vials are transported for further processing.

GNT Components used

PG1203IP

 

PG 1203IP has been specifically developed for applications in the pharmaceutical industry. To determine the vessel’s internal pressure, GNT developed this processor-controlled plasma generation system with the highly sensitive plasma detection. The PG1203IP allows to store vial format data together with predefined measurement parameters in the internal memory.

read more ..

HV Probe and Brass-tip standard

GNT HV Probes represent the link between the digital signal generation and the test objects. They contain the Tesla transformer as well as a replaceable electrode. The 2.5m long cable allows flexible use and the robust plug connection ensures reliability and safety.

HVP-3 is used for stationary applications, especially in auto-mated operation. On request, we design and manufacture custo-mized brackets to perfectly suit the requirements.

read more ..

Optical Wire

If plasma has been generated, the optical signal must be transmitted to the evaluation unit (plasma detector) inside the PG1203IP.

An optical plastic fiber is used for this purpose. The use of such a light-conducting fiber allows easy installation with low space requirements and provides a reliable protection of the sensitive detector electronics.

High test reliability, minimal product stress and non-destructive monitoring at high throughput are crucial to manufacturers as well as cost-effectiveness. GNT systems on the basis of plasma technology offer the possibility to determine and store quantitative pressure values ​​beyond a good / bad assessment. This identifies trends in production quality and process fluctuations can be compensated in good time.