Aseptic Filling Solutions
Integrated solutions for the aseptic filling of small batches in the pharmaceutical and biotechnology sectors, designed in accordance with cGMP requirements to ensure precise, repeatable filling and capping operations with controlled contamination risk.
Aseptic filling and finishing systems are configured to meet specific production needs and can integrate various process equipment, offering aseptic filling solutions suitable for a wide range of applications.
Aseptic Filling Solutions
Available Models
The product line includes pharmaceutical filling equipment, systems designed for filling and capping operations, and solutions for handling various container sizes, including machines for the aseptic filling of vials and equipment for filling syringes.
Integrations with process equipment, such as freeze-dryers, as well as with process chambers and pre-chambers—for the controlled handling of materials and various operational phases—round out the solutions for sterile filling and aseptic filling and finishingapplications , meeting the needs of research, preclinical production, and clinical production.
Access the relevant technical data sheet to learn about features, configurations, and applications.
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Appendix 1
EU GMP
Class A
EU GMP
ISO 5
ISO 14644-1
GAMP5
FDA 21 CFR Part 11
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We'll help you find the configuration that best suits your needs.
Use Cases
When Shielded Isolators Are the Right Choice
Typical situations in which shielding, containment, and operational controllability become design requirements.
High shielding required
When potential exposure requires structural protection.
Segnali tipici:
High-Risk Repetitive Tasks
Repetitive, precision tasks
When reducing manual intervention is part of risk management.
Segnali tipici:
Close manual passes
Transfer of Materials as a Constraint
When pass-throughs and airlocks determine continuity and layout.
Segnali tipici:
Bottlenecks in the Transfer Process
Constrained layout
When space and access requirements call for custom-designed solutions.
Segnali tipici:
Difficult maintenance / limited access
Operational Repeatability
When consistent procedures across shifts and operators are essential.
Segnali tipici:
Variability Among Operators
Complex Regulatory Environment
When documentation, audits, and inspections are part of the decision-making process.
Segnali tipici:
Qualification/Validation Requirements
Do any of these scenarios sound familiar to you? Talk to an expert
Approach: Synergies
Beyond the Product: Design, Integration, Continuity
Hot Cells isn't just a "catalog" option. Its value lies in how the solution is integrated and established within your context.
Integration
Design that is consistent with actual access points, utilities, and operational sequences. In practice:
- layout and accessibility for operators and maintenance personnel
- technical procedures and system interfaces
- Compatibility with workflows and material transfers
Customization
Configuration based on constraints and requirements, not on “standard options.” In practice:
- layout and accessibility for operators and maintenance personnel
- technical processes and plant interfaces
- Compatibility with workflows and transfers
Support in a Global Context
A structured launch and operational continuity over time.
In practice:
- Controlled commissioning and handover
- Operational training and procedures
- service plan, spare parts, technical support
Services
Project Support Services
Sales Services
Solutions and expertise to support your project, from the initial analysis phase through to full operation:
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Consulting
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Design and Ergonomic Analysis
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Installation and Validation
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Training
After-Sales Services
Comprehensive support even after installation, to ensure operational continuity, efficiency, and maximum performance over time:
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Maintenance Service
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Spare Parts Service
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Help Desk
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Production Support
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Training
Case Studies
Results in Real-World Settings
From the clinic to production: case studies demonstrating integration, compliance, and continuity.
Reliability
Quality and Compliance Integrated into the Design
Quality and compliance are an integral part of how we work, at every stage.
- Checks and verifications throughout the various stages
- Traceability, Requirements, and Changes
Request a Technical Evaluation
Share your requirements and project specifications: we’ll provide you with initial feedback on the solution and configuration best suited to the application you’re developing.
- Application and process requirements.
- Layout, material flows, and transfer.
- Timelines and operational goals.
Other Types in Biotechnology
Is this not the type you were looking for?
If Aseptic Filling Solutions aren't what you're looking for, check out Tema Sinergie's other solutions for the pharma and biotech industries.
QC Isolators
Sterility testing and pharmaceutical quality control isolators, designed to ensure fast processes, maximum result reliability, and compliance with cGMP regulations.
Integrity Testing Systems
Advanced devices for integrity testing of critical components of pharmaceutical isolators, such as glove ports and RTPs, designed to ensure process safety, result reliability, and full compliance with cGMP and Annex 1 regulations.
Pharmaceutical Isolators
Isolation systems for sterile and high-containment processes, designed to ensure product quality, operator safety, and regulatory compliance.