Telstar Pura 2/3/4 Sterile Test Isolator
| Brand | Telstar |
|---|---|
| Origin | Spain |
| Model | Telstar Pura 2, Pura 3, Pura 4, Pura 3+, Pura 4+ |
| Air Classification | ISO Class 5 (EU GMP Grade A) in all chambers |
| Airflow | Unidirectional laminar flow (certified per ISO 14644-1) |
| Illumination | 700 lux (test chamber), 300 lux (transfer chamber) |
| Noise Level | <70 dBA |
| Inlet Filtration | HEPA H14 (99.997% @ 0.3 µm) |
| Exhaust Filtration | HEPA H14 (99.997% @ 0.3 µm) |
| Pre-filter | E10 |
| Bio-decontamination Efficacy | ≥6-log reduction of Geobacillus stearothermophilus spores |
| Sterility Test Pump | Integrated with standard Millipore (Merck) or Sartorius filtration units |
| Non-viable Particle Monitoring | APEX P5 portable airborne particle counter (dual-channel, 0.3/0.5 µm, 3000-record memory, 3.5" color touchscreen, stainless steel 304 housing) with LMS Express software (21 CFR Part 11 compliant) |
| Viable Microbial Monitoring | Sartorius MD8 airscan with gelatin membrane filtration |
| H₂O₂ Monitoring | In-chamber single-channel sensor (0–300 ppm) |
| Validation Support | FAT/SAT/DQ/IQ/OQ/PQ documentation templates available |
| Service | Global technical support via Telstar UK |
Overview
The Telstar Pura 2, Pura 3, Pura 4, and their enhanced variants (Pura 3+, Pura 4+) are fully enclosed, rigid-wall sterile test isolators engineered for aseptic processing validation and routine sterility testing under EU GMP Annex 1 and USP <71> requirements. These systems operate on the principle of physical separation—achieving microbial control not through personnel-dependent cleanroom practices, but via engineering controls: unidirectional laminar airflow (ISO Class 5 / EU GMP Grade A), validated hydrogen peroxide (H₂O₂) vapor bio-decontamination, and continuous environmental monitoring. Each chamber is constructed from electropolished stainless steel (AISI 316L) with welded seams and double-glove ports conforming to ISO 14644-7, ensuring structural integrity, chemical resistance, and leak-tightness (<1 × 10⁻⁶ mbar·L/s He). The isolator architecture eliminates reliance on operator gowning, minimizes human intervention, and provides reproducible, auditable sterility test environments—critical for pharmaceutical quality control laboratories operating under FDA, EMA, and PMDA regulatory oversight.
Key Features
- ISO Class 5 (EU GMP Grade A) air classification maintained across all internal chambers via certified unidirectional laminar airflow, supported by dual HEPA H14 filters (inlet and exhaust) and E10 pre-filters for extended filter life.
- Validated H₂O₂ vapor bio-decontamination cycle achieving ≥6-log reduction of Geobacillus stearothermophilus spores, verified using calibrated biological indicators and real-time in-chamber H₂O₂ concentration monitoring (0–300 ppm range).
- Integrated sterility test pump compatible with standard membrane filtration assemblies from Merck Millipore and Sartorius—fully configurable for membrane types (0.22 µm or 0.45 µm), sample volumes (up to 1,000 mL), and vacuum/pressure-driven protocols.
- Comprehensive environmental monitoring suite: dual-channel APEX P5 airborne particle counter (0.3 µm and 0.5 µm thresholds), Sartorius MD8 airscan for viable microbial sampling via gelatin membrane filtration, and redundant H₂O₂ sensors (in-chamber and ambient).
- Regulatory-compliant data management: LMS Express software enables secure, time-stamped, user-authenticated data acquisition, audit trail generation, electronic signatures, and full compliance with 21 CFR Part 11 and EU Annex 11 requirements.
- Modular configuration options: Pura 2/3/4 (single-chamber, batch-mode operation) and Pura 3+/4+ (dual-chamber, continuous throughput design with independent decontamination cycles for transfer and test zones).
Sample Compatibility & Compliance
The Telstar Pura series accommodates a broad spectrum of sterile test sample formats—including vials, ampoules, syringes, IV bags, and prefilled devices—as well as associated media, filters, and accessories. All materials in contact with the process environment (gloves, gaskets, tubing, and interior surfaces) comply with USP <88> Class VI biocompatibility and ISO 10993-5 cytotoxicity standards. The system meets ISO 14644-1 (air cleanliness), ISO 14644-3 (testing methods), ISO 14644-7 (separative devices), and ISO 14698-1 (bio-contamination control). Design and operational qualification align with ICH Q5A(R2), EU GMP Annex 1 (2022 revision), and ASTM E2994-15 (standard guide for isolator qualification). Full validation lifecycle documentation—including DQ, IQ, OQ, PQ, and risk assessments per ISO 14971—is supported by Telstar’s qualified validation engineers.
Software & Data Management
LMS Express serves as the central data acquisition and supervisory platform for the Pura isolator. It operates on Windows-based industrial PCs with role-based access control (RBAC), multi-level user authentication, and encrypted local database storage. All environmental and operational parameters—including particle counts, H₂O₂ concentration logs, glove pressure differentials, airflow velocity, and sterilization cycle timestamps—are recorded with millisecond precision. Audit trails are immutable, timestamped, and include operator ID, action type, and parameter values before/after change. Electronic signatures adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and satisfy FDA 21 CFR Part 11 Subpart B requirements for electronic records and signatures. Data export is available in CSV, PDF, and XML formats for integration into LIMS or QMS platforms.
Applications
The Telstar Pura isolators are deployed in QC laboratories for compendial sterility testing (USP <71>, Ph. Eur. 2.6.1, JP 4.07), media fill simulation studies, environmental monitoring method verification, and aseptic process simulation (APS). Their modular architecture supports integration with ancillary equipment—including freeze-dryer loading interfaces (e.g., ATLUS automated tray transfer), reactor coupling for high-potency API handling, and weigh-in-balance systems for closed powder dispensing. In R&D settings, they enable safe manipulation of cytotoxic compounds, oligonucleotides, and viral vectors under containment conditions meeting ISO 15378 and PIC/S TR 74 requirements. The Pura 3+/4+ configuration is particularly suited for high-throughput biologics release testing where continuous sample ingress without environmental interruption is required.
FAQ
What regulatory standards does the Telstar Pura isolator comply with?
The system conforms to EU GMP Annex 1 (2022), ISO 14644-1/3/7, ISO 14698-1, USP <71>, Ph. Eur. 2.6.1, and FDA 21 CFR Part 11 for electronic records.
Can the isolator be integrated with existing laboratory information management systems (LIMS)?
Yes—LMS Express supports OPC UA and CSV export for seamless bidirectional data exchange with validated LIMS/QMS platforms.
Is validation support provided for installation and operation?
Telstar offers comprehensive qualification services including FAT, SAT, DQ, IQ, OQ, and PQ, with fully editable protocol templates aligned with ISPE GAMP 5 and ASTM E2500.
What is the typical lead time for commissioning and operational qualification?
Standard commissioning (including IQ/OQ execution and report issuance) requires 6–8 weeks post-installation, subject to client readiness and facility utility availability.
Are spare parts and consumables supplied globally?
Yes—Telstar maintains regional distribution hubs in the UK, USA, China, and Germany, with critical spares (HEPA filters, gloves, H₂O₂ sensors, gaskets) stocked for 48-hour dispatch.
