Lindner Group and J&K Consulting have agreed to work together.
With the cooperation of Lindner SE | Clean Rooms and J&K Consulting, customers will benefit from both the experienced clean room manufacturer and the experts in cGxP and will receive processing rooms fully compliant and ready to operate.
Lindner SE | Clean Rooms
Its comprehensive range of disciplines as a full-service provider for nearly all applications is unique. With more than 7,500 people overall, the Lindner Group continuously works on 2,500 customer projects every day and operates subsidiaries in more than 20 countries from its headquarters in Arnstorf, Bavaria.
Lindner SE | Clean Rooms is an internationally established full-service contractor for clean rooms, laboratories and operating theatres. The company realises projects in the areas of pharmaceutical, sterile and hospital environment (ICUs, OTs etc.), microelectronics and semiconductor production around the world.
With more than 30 years of experience, Lindner SE | Clean Rooms has a leading role in the construction of clean room solutions: By developing state-of-the-art products and providing professional construction management, it make efficient project management possible. The deep vertical integration of production allows maximum flexibility – especially for project-related solutions.
Lindner SE | Clean Room division supports in:
- Complete solutions for clean rooms
- Clean room construction management
- Consulting and planning of clean room facilities
- Production of modular clean room systems
- Training of employees
- Completion and maintenance of the clean room
- Analysis of the requirements for the clean room
- GMP- and DIN EN ISO 14644 conform installation
- Outstanding engineering and design – made in Germany
Advantages of Lindner SE | Clean Room division:
- Internationally operating large company with decades of experience in clean room construction for the pharmaceutical industry
- Focus on the compliance with GMP, DIN EN ISO 14644 and VDI 2083
- Complete solutions for all types of clean rooms
- In house development and production of fit-out products solely in Germany
- Safe future investment due to modular, interchangeable, standardised construction
- Test certificates for all clean room products
J&K Consulting
J&K Consulting GmbH specialises in the needs and requirements of the regulated industry, particularly in the area of cGxP compliance as well as the development of new processes in the pharmaceutical industry. With the software CVal, developed by the J&K Technology GmbH, combined with the COMOS software, digitalisation of your whole facility is efficient to handle. The realisation of GACP and GMP is multi-layered and complex in its implementation, especially where it is combined in a clean room situation for the pharmaceutical industry. Therefore, as a long-term partner of researching and producing pharmaceutical companies, we solve this situation to enable a sustainable development in combination with an agile service for projecting.
J&K Consulting supports in:
- Digitalisation of business processes with cGxP conformity
- With their knowledge in COMOS/CVal they can quickly complete all the necessary processes in terms of object-based document management and are able to perform risk analyses
- Design of processes for cGxP conformity
- Development and preparation of specifications
- Implementation of your processes with cGxP conformity
- Qualification and validation
- Setup of a cGxP organisation including implementation and establishment of QM processes
With their detailed knowledge about the Lindner clean room systems and the present documentation they can offer a fast and cost-efficient validation of the needed processes. The Lindner documents include the documentation from FS to PQ. To use the system according to GMP and GACP guidelines in your facility there a still some steps to go, which J&K will lead. With their knowledge and skills, they are the link between you, Lindner and your success.
J&K Consulting offers:
- User requirement specification for your individual clean room situation
- Rapid Implementation of qualification and documentation in COMOS/CVal
- Full digitalisation with COMOS/CVal vs. different stand-alone solutions: J&K offers integrated solutions of full digitalisation of the business process over the full life cycle due to a digital twin: Specification, test, deviation, traceability, change, risk, project phase and document phase management
- Therefore, maintenance and planning of inventory or equipment is easier to handle
- Planning/definition of requirements for pharmaceutical production facilities
- Risk analysis
- Implementation and establishment of QM processes
Cooperation Lindner SE | Clean Rooms and J&K Consulting
With the cooperation of Lindner SE | Clean Rooms and J&K Consulting you benefit from both the experienced clean room manufacturer and the experts in cGxP and receive your processing rooms fully compliant and ready to operate.
Advantages:
- Clean rooms can be rapidly planned and qualified according to the modular principle
- Tailor-made for your specific application, especially for the cannabis industry
- High quality and efficiency, engineered and made in Germany
- Full service for maintenance and troubleshooting during the whole lifecycle of the clean room
- Fully compliant to GMP and therefore the GACP guidelines as well
- Establishment of high-quality standards
- Reliable and optimised processes
