Glatt enters into biopharma equipment business
A New Milestone: Manufacturing Skid Bioprocessing Suites for Insulin Production in Egypt
We are delighted to announce a significant achievement for Glatt: the successful manufacturing of bioprocessing suites for insulin production for a client in Egypt. With the successful Factory Acceptance Test (FAT), this project marks our first venture in the bioprocessing sector outside of Asia, demonstrating our ability to meet diverse market demands while maintaining the highest standards of quality, innovation, and regulatory compliance.
Project Scope and Overview
The project involves the design and manufacturing of skid bioprocessing suites with capacities of 100L, 300L, 500L, and 1250L. These systems are developed for critical processes such as charging, formulation, filling, and preparation of Clean-In-Place (CIP) solutions. Certified under PED (Pressure Equipment Directive) and CE standards, the skids also comply with ASME BPE (BioProcessing Equipment) guidelines and 21 CFR regulations, ensuring they meet stringent safety and quality requirements for pharmaceutical applications.
As a “fully integrated” solution Glatt has created another impressive and important customer-reference here.
Key Design Features
The bioprocessing suites are equipped with advanced features tailored to the specific needs of insulin production:
- Mixing Efficiency: Bottom dish-mounted magnetic mixers ensure precise and efficient mixing
- Aeration: Sintered spargers allow controlled aeration for optimal process conditions
- Instrumentation: Provisions for pH and DO sensors on the tank shell enable real-time monitoring
- Weight Measurement: Load cells integrated into the design provide accurate weight calculations
- Accessibility: Hand holes and shell-mounted J-tubes facilitate product addition and maintenance
Successful FAT of the skid bioprocessing suites for insulin production in Egypt
Hygienic Design Principles
To prevent contamination risks and ensure easy cleaning, the skids are constructed with smooth non-reactive surfaces, sanitary welds, sealed joints, and optimized drainage. These features eliminate dead zones, ensuring thorough cleaning during CIP operations. The integration of both CIP and Sterilize-In-Place (SIP) systems allows automated cleaning and sterilization without disassembling equipment. The CIP system includes spray balls, sanitary valves, and strategically placed nozzles for uniform cleaning. The SIP system uses steam injection to sterilize all internal surfaces effectively.
Regulatory Compliance
This project adheres to internationally recognized standards to ensure safety, hygiene, and performance. GMP compliance is achieved by incorporating validated processes, traceability measures, and comprehensive documentation throughout the manufacturing process. All materials used in the skids are FDA-approved to guarantee product integrity and prevent contamination risks. Additionally, regulatory documentation such as material certificates, welding records, inspection reports, CIP/SIP validation documents, Certificates of Compliance (CoC), IQ/OQ/PQ documentation, and user manuals are meticulously prepared to meet global standards.
Collaboration is Key
This project exemplifies Glatt’s ability to leverage its global expertise through seamless collaboration between various teams. The engineering team provides critical insights into block valve design and sterility compliance, ensuring the skids meet the highest operational and regulatory standards. Manufacturing teams optimize the multi-batch system to deliver CAPEX and OPEX benefits for the client, demonstrating our commitment to cost-effective and efficient solutions. Regulatory teams ensure strict adherence to PUPSIT (Pre-Use Post-Sterilization Integrity Testing) requirements, aligning the project with global sterility norms.
Competitive Advantages
Glatt’s competitive edge in securing this project lies in its combination of technical expertise, innovative design, and customer-focused solutions. The modular design approach enables the client to handle various products efficiently within their production setup, while the integration of a multi-use PUPSIT system ensures compliance with stringent sterilization norms. The block valve design reduces manual intervention, improving operational efficiency and reliability.
A key factor in winning this project was Glatt’s ability to provide detailed pre-order 3D visual models, allowing the client to clearly understand the proposed solution early in the decision-making process. A factory visit further validated Glatt’s technical expertise and manufacturing capabilities, reinforcing the client’s confidence in our ability to deliver high-quality equipment.
This milestone represents a pivotal step in expanding our global footprint. By entering the African market with such a critical project, we are opening doors to future opportunities in this rapidly growing region. It also reinforces Glatt’s reputation as a trusted partner capable of delivering innovative solutions tailored to diverse market needs.
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