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Product catalog summary
Introduction
Martin Christ is a prominent company in the development and manufacturing of freeze dryers, with over 65 years of experience. They specialize in customized systems for sterile pharmaceutical production, ensuring high customer satisfaction and compliance with pharmaceutical standards.
Technological Innovations
Martin Christ is known for its innovation in freeze drying technology, including the wireless product temperature measurement system WTMplus. The company holds numerous patents, showcasing its leadership in the field.
Freeze Drying in Pharmaceutical Production
Freeze drying is essential for the shelf life of sensitive pharmaceutical products. Martin Christ provides systems that are chemically resistant and comply with safety requirements, ensuring aseptic production with automatic loading and unloading systems.
System Design and Efficiency
The company offers a double-chamber system design that optimizes water vapor flow, reduces processing times, and increases cost-effectiveness, particularly for temperature-sensitive materials.
Features of Epsilon DS Freeze Dryers
The Epsilon DS freeze dryers are customizable, space-saving, and equipped with advanced automation and safety features, including validated CIP cleaning and integrated filter tests.
Customised System Layout
Martin Christ provides tailored freeze drying systems based on product quality, space, and cost-effectiveness, designed for long-term use and future adaptability.
Energy-Saving Refrigeration Systems
The refrigeration systems use standard piston or screw compressors with intelligent energy management for low energy consumption, and redundancy is standard in larger systems.
Vacuum Systems
Equipped with rotary vane pumps, the systems offer redundancy in larger setups, with oil-free vacuum pumps available as an option.
Shelf Design
Shelves are made from high-quality stainless steel for even temperature distribution and robust construction, customizable based on client requirements.
Cleaning and Sterilisation
Automatic CIP cleaning and steam sterilization (SIP) are validated and use the same piping system, with a filter integrity test ensuring proper operation.
Automation and Process Control
The automation concept integrates industry standards with freeze drying processes using Siemens S7-400 control systems and LPCplus software for optimal control and communication.
Conclusion
Martin Christ's freeze dryers offer comprehensive monitoring and quality assurance functions, with user-friendly software for process control and documentation, ensuring compliance with industry standards.
Overview of 21 CFR Part 11 Compliance
The document discusses compliance with FDA's 21 CFR Part 11 regulations, emphasizing data integrity and security in electronic systems.
Process Control System - LPCplus
LPCplus is a process control system compatible with Windows-based PCs, allowing remote access for maintenance and supporting configurable CIP, SIP, and FIT processes.
Freeze Drying Process Visualization
LPCplus provides tools for process visualization specific to freeze drying, including graphical generation of drying programs and analysis of multiple freeze dryer runs.
Data Integrity and Security
The system ensures data integrity with tamper-proof binary formats and a single audit trail, including detailed user administration to prevent unauthorized changes.
Monitoring and PAT Tools
LPCplus integrates PAT tools for process control and optimization, archiving data in a GAMP 5-compliant format, and offers wireless product temperature measurement.
Loading and Unloading Solutions
Various solutions for loading and unloading freeze dryers are discussed, including the innovative LyoShuttle system with advantages like no moving parts above vials.
Isolation Technology
The document describes the use of isolators and RABS systems for aseptic production, ensuring product and operator safety.
System Integration and Special Solutions
Martin Christ offers customized solutions for freeze drying systems, including alternative cooling systems and extensive PAT tools.
Overview
This document outlines the procedures and services provided by Martin Christ for the installation, testing, and maintenance of freeze drying systems, ensuring compliance with GMP standards.
Key Sections
1. Testing and Qualification Procedures
Describes the FAT and SAT processes, confirming the freeze dryer's ability to meet task requirements, and covers DQ, IQ, OQ, and PQ stages for comprehensive validation.
2. Project Management
Martin Christ provides dedicated project managers to oversee projects from design to SAT, ensuring quality, cost, and time objectives are met.
3. Maintenance and Support
Regular maintenance and revalidation services are offered to ensure ongoing compliance and minimize downtime.
4. Global Service Network
Martin Christ operates in over 70 countries, providing local support through a network of partners for quick response times.
5. Product Range
The company offers a wide range of freeze drying systems and vacuum concentrators for various applications.
Conclusion
Martin Christ emphasizes quality and customer satisfaction, offering comprehensive solutions and support throughout the lifecycle of their freeze drying systems.
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Catalog excerpts

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Freeze Drying Systems for Pharmaceutical Production Customised Solutions Designed & Made in Germany

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Martin Christ is a world leader in the development and manufacturing of freeze dryers, with over 65 years of experience. We would now like to invite you in the following pages to learn a little more about at the developments outlined above. We want to present to you now the centrepiece of our company – the area in which all our expertise and experience come together: We are talking about the construction of customised systems for sterile production of pharmaceutical products. In this sector too, the name Martin Christ stands for utmost customer satisfaction all over the world. We develop and...

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Optimised system design for aseptic production of active substances For GMP processes in the fields of pharmaceutical, diagnostic and specialist applications we offer the double-chamber principle, developed by us, with a large opening to the ice condenser positioned below the drying chamber. The large cross-section creates ideal flow conditions for water vapour. Especially at the start of the drying process, undesirably large pressure differences between the drying chamber and the ice condenser chamber can occur if the opening is not large enough to handle the enormous quantities of water vapour...

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Advantages of the Martin Christ Epsilon DS freeze dryers: • Customised, and space-saving due to compact frame design • Process specific system configurations such as door designs with door-in-door variants, or slot door and separate inspection door • Automation with Siemens S7 and user-friendly process visualisation LPCplus • Safe operation than ks to redundant systems • Effective and validated CIP cleaning • Integrated, fully automatic filter test (FIT) • Pressure chamber > 2.5 bar for steam sterilisation (SIP) from 121 °C up to 135 °C • Hydraulic-pneumatic door locking system • Thoroughly tested...

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6 Routine applications | LDplus Display

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Customised System Layout The main criterion in selecting a freeze drying system is the desired quality of the final product. Combined with other requirements, for example with regard to incorporation into process sequences, space requirements, high cost effectiveness, and compliance with all relevant legal requirements. Based on our tried and tested double-chamber principle, we plan and implement your requirements: product-oriented, process-optimised and adapted for each individual application. Your process decides The integration of the system technology into the process flow must be guaranteed....

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Detail Engineering at the Highest Level Tailored and energy-saving refrigiration systems Cooling systems of production freeze driers normally use standard commercially available piston compressors, which are equipped with up to six independent cooling systems depending on the size of the system. As an alternative when power requirements are high, screw compressors can be installed. During the freezing process the entire cooling system works primarily for shelf temperature control, and during the drying process – depending on the process section – mainly on the ice condenser. The intelligent energy...

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Best quality shelf design The shelves for the pharmaceutical product are made from highquality stainless steel. They are welded together with the latest laser methods and achieve a surface finish of Ra ≤ 0.6 µm. The eveness is ± 0.5 mm over the entire shelf. The FEM-optimised design used results in a robust and yet weightsaving layout. Heating and cooling times are reduced. The temperature distribution on the shelf and over the entire set of shelves is ± 1 Kelvin. This temperature distribution is being demonstrated by shelf mapping as part of the acceptance process at our factory. The number...

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Cleaning of the freeze dryer is normally carried out automatically with Cleaning in Place methods – or CIP for short. In this method the entire drying chamber including the shelves, hydraulic cylinder bellows and the ice condenser chamber with the ice condenser coils can be reached by the integral conical nozzle system. This fully automatic cleaning process is validated and complies with the ISO 13408 guidelines. In recent years the circulation method with its reduced volume flow has become more and more industrial standard. Process sequence (example): 1 Cleaning step in the continuous method...

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The CIP process is normally followed by steam sterilization, or SIP (Sterilization in Place). Again, this process is validated and runs fully automatically. Steam sterilization and cleaning process use the same set of piping. By exact determination of the cold spot in the overall system (on the ice condenser drain) and monitoring of the temperature at this point, the sterilization process is controlled in an adjustable manner using the LPCplus process visualisation software (pressure or temperature, duration). The filter integrity test (FIT) is usually used to test the proper operation (“integrity”)...

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Application Optimised Automation Concept The Martin Christ automation concept combines the standards of leading process automation solutions with the focus on the freeze drying processes of the pharmaceutical industry. This results in a corresponding system for both the process viualization and the process data management. • Siemens S7-400 control system • Process visualization with the Martin Christ LPCplus process control system • Integration and interfacing of loading and unloading with other external systems • Operation of several stations, e.g. in the clean room and the control room • Intrinsically...

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Process Visualization Specific to Freeze Drying Production freeze dryers in the pharmaceutical industry should offer more than just comprehensive monitoring of running processes – e.g. functions for quality assurance. Martin Christ units feature fully automatic process control with direct parameter adjustment to give you optimal protection against spoiled batches of your valuable products. Process visualization with LPCplus Our user-friendly software for process and system control provides a uniform user interface for all freeze dryer functions and associated administration tasks. The SCADA software...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.