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PH21 - An Evolutionary History

The PH21 was 'born' in 1993 as a pure laboratory quality control software package for universal tablet testers running on 386 CPUs under the Microsoft Windows 3.1 operating system (or better say DOS with graphical supplement). The letter code was 'LM' and the revision was 1.xx. This evolved to the 'MI' revision 2.xx. Here several in-process-control functions were added. 1995 the revision changed to 3.xx. Other kinds of measured values (manual values) were added as well as other equipment supported (container filling systems, barcode operation). In 2000 work for the revision 4 update started. Main motivation was to make full use of the Microsoft Windows 32-bit features and new database technologies. Currently several hundreds of PH21 shipments are at work worldwide at customers satisfactions. The PH21 system is a de-facto standard for solid dosage testing and will continue its existence and improvement far into the 21 century.

 

An overview of the various components constituting the PH21 Software.

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The PH21 Software is designed with special attention to the following properties:

The PH21 system consists of:

Openness

The openness of the PH21 system is accomplished by the following dedicated features:

All test equipment is connected via a standardized, serial measurement-bus (DIN 66384). Up to 30 devices may be connected to a single PC . A proven SQL database (Microsoft ACCESS 97) is the pivot point of the system. Batch quality data may be transferred automatically to any local or networked disk drive.

 

Scalability

The PH21 system may be used to operate a single tablet tester in a conventional laboratory environment, or the PH21 system may drive up to 30 devices in a realtime in-process control application.

 

Robustness

The PH21 system is designed for lights-off operation in an in-process-controlled environment. All significant events are logged and may be analyzed at a later time. The database server consists of an integrated transaction-logging mechanism. In case of power failure or another catastrophic event the system may re-started using a previous state of the database. For this purpose The PH21 system always keeps copies of the last 10 recent database states. This improves the robustness of the whole system.

 

Security

Every button may be assigned an access restriction level. Every user group got its individual access restriction, a numerical value from zero (no access restriction/super user) to nine (maximum access restriction/low priority user). This access control scheme can be fine-tailored to any customer's security requirements.

 

Compliance

From the beginning of the system design special care has been taken to ensure the proper operation of the system. So our verification/validation scheme was born, using irl's unique pseudo-random-number generator incorporated into every PH21 compatible device. With the help of irl's validation documentation the correctness of the system can be verified at any time and any place (also at the customer's site).

The PH21 R4 fully complies to the latest 21 CFR Part 11 requirements. This has been acknowledged by major pharmaceutical corporations.

 

The PH21 software foundation module

The foundation module consists of all functions which are device independent. These are among others:

Because of this data will only be set up (and maintained) once for all connected devices, the overall system maintanance effort will be significantly reduced compared to a 'one device/one PC' solution.

The PH21 device specific application modules

Every connected device will be represented in the PH21 system by its specific application module. Click here for sample application 1, sample application 2 window.

Online Data Transfer

The online Datatransfer module enables the exchange of Test results between PC in a network.

 

Alarms

The arlarms are an extended features of the Desktop Application. They apply tio Batches and to products.

Batches/Alarm

Aalarm parameters canl be temporarily modified for a running batch'. Alarm actions can be suspended for particular batches

Product/Alarm

Alarms types are selected during Product setup.Alarm parameters defined in the product data will become effective when a new batch will be started and remain until the batch is deleted or the batch is modified.

 

 

Barcode

The barcode is testing method in which the test dataset are scan and automatically recognised by the Tester. All the user has to do is to start the test.

 

Reduced Functionality system

This is a version of the UTT Application that can used with a weighing system to collect and evaluate the weights of tablets, Blood bags,etc.

 

Biometric signature

This is a secured system used to certify that duties have been carried out by the signatories.

 

RealTime data exchange

For some applications of the PH21 software system it may be convenient to have the ability to route the data of a test equipment to another device in real-time e.g. just when the data is generated.

One application may be the close-loop control chain of a tablet press and a tablet weight/hardness tester. Tablet tests may be performed either in predefined time intervals or by an external trigger from the tablet press. The measured weight and/or hardness values will then be sent via a RS232 serial line to the tablet press controller for adjustment of press force and granulation feeding.

 

 

Control charts

Control charts provide a visual control of the testing system.A Control chart entry may be generated for a specific monitoring. If an alarm type has been assigned, the control chart will be activated automatically. You may use the control chart to view and to confirm pending alarms.only those statistical values for which monitoring have been defined appear in the control chart.

 

External test device

Ttest results from external test devices could easily be evaluated using the PH21 software by using this interface. for more information about External test device click here other test devices.

 

Confirmation of Batches

This functionality permits the quality controller to confirm test Batches according to the test standards applied.

 

LIMS integration

For the universal tablet tester and for the disi disintegration tester an addon has been developed for the integration of the test systems into a customer's LIMS system. In a pharmaceutical networked IT environment, it is of a great importance to assure a continuous quality production control of the solid forms and to integrate these in a customer’s Laboratory Information System (LIMS). The integration generally consist of two information flow channels:

  • Test information flow from a LIMS to a laboratory test device (download - path)
  • Return of test data and statistical results from a laboratory test device to a LIMS system (upload - path).

This Information exchange should be done 'online', i.e. with as less assistance from the user as possible

 

QM Packages

The QM Packages of Team PH21 are the Back bones of Team PH21 Software Development. more.

 

 

Two sets of tolerance

These are the two upper and lower Teolernace Limits defined in the product data.

 

Supplements/ Options

These are additional components of the PH21 systems which could odered as addons.

 

Extended Features

These component are available in the standard PH21 systems and can be activated when needed. They comprise of the following:

 

PH21 Standard system

PH21 standard system are the basic system that can be bougth. The PH21 standard system comprise of the following Apllications:

 

 

IPC-Features

This is the in process control system which can be set to improve the quality of the production during the production process.