Flexible and reproducible production is vital in the pharmaceutical, biopharmaceutical and cosmetics industry. The key requirements of this industry are without doubt increasing standardisation and optimisation of the production processes and adherence to international obligations on supporting documents. The solution to these complex tasks can only be provided by an automation system which controls, monitors and analyses all the production processes in an integral and secure manner.
Our years of experience in this industry are based on concept development and the realisation of integrated and intelligent MES and automation solutions. Furthermore, with our in-house developed process control system Plant iT we boast a proven solution for integrated process automation, including MES functionality. Our GMP-compliant solutions satisfy international regulations, e.g. FDA 21 CFR Part 11 Electronic Records and Electronic Signatures. Find more information on Good Manufacturing Practice (GMP) with Plant iT here.
Numerous companies, such as Bayer, Fresenius Kabi or Merck, have relied on our solution skills and expertise for many years.
Sales Manager, ProLeiT Inc., USA
Phone: +1 224 880 6536
Head of Sales, Food, ProLeiT GmbH, Germany
Phone: +49 9132 777 142
Sales Manager, Life Sciences, ProLeiT GmbH, Germany
Phone: +49 9132 777 441
Our integrated, transparent and flexible process control system Plant iT provides the ideal software structure for production plants in the chemicals and fine chemicals industry. Plant iT is an advanced and industry-specific system solution which combines extensive IT experience and chemical expertise in a single control system. It is the perfect option for both new installations, expansions or as a replacement for existing automation systems.
We offer automation solutions for the following production areas:
- Goods receipt
Materials management, warehouse management, logistics
Process-oriented experimental procedures
- Filling and packaging
Packaging management, effectiveness management (OEE), production data management
- Auxiliary plants
Building engineering, supply engineering, energy management, package units, GMP monitoring
Order management, recipe management, production process, process engineering processes, weighing and dosing (automatic/manual), preparation and mixing systems, processing plants (batch or continuous), cleaning (CIP/SIP)
Our industry-specific know-how is also based on years of cooperation with machine and plant suppliers with whom we have automated various plants. Besides the commissioning and extension of our control systems, we also offer advice and guidance on the introduction of comprehensive MES (Manufacturing Execution System) solutions for production facilities.
Our service portfolio provides the solutions for both the general and the special requirements of the pharmaceutical, biopharmaceutical and cosmetic industry. Typical examples are:
- Integrated process automation from raw material delivery to packaging
- Mixing and stirring tank systems
- Container handling
- Aseptic and sterile plants
- Spray drying plants
- Powder processing plants
- Heat recovery plants
- Building control systems, high bay racking and ventilation systems
- CO² plants
- Water supply
- Water treatment plants
- Wastewater plants
- Cooling plants
- Energy data acquisition
- Intelligent load management
- Automatic tank management
- Management reporting across process boundaries
- Migration of existing control systems
The success of our customers is based, among other things, on the tried-and-tested functions of our in-house developed process control system Plant iT. The integrated functions provide intelligent solutions to meet the following requirements:
- Batch systems according to ISA S88 for batch and continuous processes
- Order lists for production, cleaning and filling
- Recipe-controlled program sequences
- Uniform material and raw material management
- Batch traceability (pre and post-tracking) to EU Regulation 178/2002
- Company-wide management reporting
- MES functionalities for planning, guidance, analysis and evaluation of production processes
- Production-based documents and logs for company-wide analyses
- Electronic batch recording for batch-related messages and graphs
- Electronic signature
- Recipe optimisation
- FDA-compliant reports for adherence to international regulations
- Label and barcode handling
- Technical automation classes for network and device diagnosis of PLCs, clients, servers and decentralised peripheral equipment
- Technological automation classes for materials handling technology and route control, and for frequency converters (e.g. Danfoss VLT, SEW, Simovert)
- Technological automation classes for weighing technology (e.g. SIWAREX U/M, Schenck, Disocont/Disomat, Systec IT 9000, weigh scales software)
- Interfaces for the connection of various ERP systems (e.g. SAP/R3, CHARISMA, FOSS)
- Interfaces for connection to laboratory management systems (LIMS), e.g. Unilab
- Interfaces for the connection of existing weighing systems
Our control system Plant iT is characterised by a high level of standardisation, integration and the elimination of unnecessary interfaces (lean thinking). Our key goal is the automatic generation of electronic batch records and continuous material tracking throughout the entire production process. Thanks to the integration of MES and PCS in a single system, we achieve greater production quality combined with reduced plant running costs. Besides expansions and new plants (green field projects), our process control system Plant iT is particularly suitable for the migration of old plants, as it supports the programmable logic controls (PLCs) from Schneider Electric, Siemens and Rockwell Automation. Another major advantage of Plant iT is that end customers as well as machine and plant suppliers only have to be familiar with just one system, irrespective of the subordinate control platforms from other manufacturers.
Plant iT provides an integrated system platform for automation solutions in the process industry. The process control system covers the complete range of automation and information technology – from the field level to the corporate management level.
The systems have become increasingly popular in the pharmaceutical industry since 1999 and have been and will continue to be adapted to the growing number of requirements demanded by European and US authorities.
Regulation 21 CFR Part 11 of the US Food and Drug Administration (FDA) became effective on 20 August 1997. The regulation describes the FDA requirements on the use of electronic records and signatures instead of traditional paper records. Generally speaking, these electronic records must provide the same level of performance as would be the case with paper records. Furthermore, there is the possibility of using a combination of electronic and paper records.
What is 21 CFR Part 11?
The "21 Code of Federal Regulations (CFR), Part 11" details the legal provisions of the US Food and Drug Administration (FDA) on the use of electronic records and electronic signatures.
The regulation, which became effective on 20 August 1997, was developed over a period of six years in collaboration with various authorities and the pharmaceutical industry. Part 11 of this regulation specifies the legal requirements for the acceptance of electronic records and signatures as equivalent to paper records and handwritten signatures executed on paper. Part 11 assumes the risk of manipulation and non-traceable changes to electronic records and signatures is greater than for paper records and signatures, meaning additional measures are necessary.
Records required by the FDA
Plant operators subject to FDA regulations must manage various records for the products which they manufacture. 21 CFR Part 211, Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals, Subpart J, defines them. The explicitly required records and reports contain the following:
- Logs of device application and cleaning
- Records of raw materials, packaging and labelling
- Central production and control records
- Batch production and control records
- Laboratory reports
- Sales reports
For some of these records, e.g. the batch records, large parts of the required information are recorded or created by a computer system. The requirements placed on the type of information are not affected by Part 11.
In its Compliance Policy Guide 7153.17, the FDA specified regulations for the implementation of 21 CFR Part 11 in which FDA inspectors are granted greater freedom with regard to regulatory measures. The FDA does not issue certificates for products, e.g. Plant iT, and no other independent authority is permitted to do this. The plant operator must always satisfy the specifications of 21 CFR Part 11 according to the specific application. Whether the prerequisites are satisfied is decided for each specific case.