BPT
BPT
The BPT was designed specifically to perform Bubble Point Tests automatically and is fully compliant with GMP regulations. The BPT’s exceptionally high level of reliability and safety is essential for reducing operating costs.
Designed and Manufactured by Tema Sinergie
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Designed for Your Process
CRP Compact is designed to stabilize a critical phase: the dispensing and capping of vials under sterile conditions, reducing manual intervention and batch-to-batch variability. Its value lies not only in automation, but in its ability to adapt to real-world production needs: handling of open/closed vials, different capping strategies, and customizable workflows.
In regulated environments, this operational consistency results in a process that is more controllable and easier to transfer between shifts and production lines.
- Customized workflows with dedicated kits
- Vial format change even between successive batches
- Crimp and push-fit management (depending on the version)
FEATURES & BENEFITS
Key Features
BPT is an extremely versatile tool, designed to integrate with any filter that requires an integrity test before and after the dispensing process.
Flexibility
It is suitable for performing integrity tests on vented and non-vented filters. It can be used as a standalone unit or integrated with any Tema Sinergie automatic dispenser, easily adapting to various operating configurations and different laboratory workflows.
Operator Safety
Thanks to its high level of automation, BPT minimizes operator intervention, optimizing processing times and significantly reducing the risk of error.
Simplified Reporting
Data management, report generation, and information storage are simple and intuitive, ensuring immediate traceability of the process.
Method
How We Manage Department Operations
A "clinical-first" approach: reduced surgical risk, consistent procedures, and support until stabilization.
Step 01
Design Focused on Clinical Use
Solutions designed to accommodate shifts, schedules, and department-specific constraints.
Step 02
Built-in security (not an add-on)
Radiation protection and procedures: an integral part of the project, not an afterthought.
Step 03
Start-up and training to stabilize the department
Quality becomes apparent after delivery: commissioning and training reduce variability.
Step 04
Solutions designed to address shifts, schedules, and departmental constraints.
Reduce downtime and manage the department's evolution with clear support.
Settings and Customization
CRP Compact is highly customizable to meet specific production needs, vial types, and capping strategies.
Precise
It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.
Multitracer
It can be used to process a very wide range of radiopharmaceuticals in vials, always in full compliance with the latest GMP specifications.
Automatic
It automates the entire radiopharmaceutical dispensing process, minimizing the need for manual intervention by the operator.
Compact
Thanks to its compact size, it can be installed in any type of shielded laminar flow chamber equipped with a well for a calibrator and a remote gripper.
Open-Vial Filling Station
The refilling station is equipped with a 0.22 µm filter that sterilizes the radiopharmaceutical at the end of the dispensing line.
Capping Station
Crimping Station
Capping Station
Push-Fit Capping Station
The Plus version of the CRP Compact features a vial closure system with push-fit caps.
Disposable Plate Kit
Removable anodized aluminum plate, equipped with a dedicated mounting slot for quick, secure, and error-proof installation of the single-use kit.
External scale
High-precision external scale for weighing the stock solution.
Built-in scale
High-precision scale integrated into the filling station for weight-controlled dispensing.
Bubble Point Sensor
PRODUCT OPTIONS
Additional Features and Options
Push-Fit Capping Module
Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.
Push-Fit Capping Module
Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.
Push-Fit Capping Module
Add the ability to seal vials with a push-fit cap for greater versatility and flexibility in the process.
Additional Features
Configuration Details
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Additional Features
Configuration Details
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Additional Features
Configuration Details
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Key Features and Functions
Vial Sealing Modules
Workflow Adaptability
Process Integration
Technical Specifications
| Feature | Value |
|---|---|
| Volumetric Accuracy (Weight) | <1% (deviation) |
| Vial Compatibility | Open / Closed (with piercing module) |
| Type of closure | Crimp (stopper + ring), Push-fit |
| Dispensing Speed | Up to X ml/min (depending on the vial) |
| Volumetric Accuracy (Weight) | <1% (deviation) |
Case Studies
Results in Real-World Settings
From the Clinic to Production: Case Studies Demonstrating Integration, Compliance, and Continuity.
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