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Pyromega

Pyromega

Pyromega

Product catalog summary
Overview
The document outlines the technical specifications and features of the MicroSter® and PyroMega dry heat depyrogenising ovens, emphasizing their application in research laboratories and pharmaceutical settings. It highlights their compliance with industry standards and the advanced control systems integrated into these ovens.
MicroSter® Features
The MicroSter® oven is tailored for research and quality control environments. It includes a thermal printer for recording cycle events and parameters, and a PLC-controlled supervisory system with a color touch-screen HMI, control lights, push buttons, and a graphic register for enhanced user interaction.
Control Systems
The document details two control systems: the HMI MicroSter and the SCADA PharmaSter. The SCADA system is equipped with a PC and TFT color display, facilitating process supervision, control, and data management in line with 21 CFR Part 11 guidelines, ensuring regulatory compliance.
PyroMega Design and Construction
PyroMega ovens are constructed following cGMP guidelines and comply with ISO 9001, USP, and EU pharmacopoeias. They feature a centrifugal fan, HEPA filters, and a stainless steel chamber to ensure uniform air distribution and effective cooling. The design prioritizes durability, ease of maintenance, and ergonomic handling.
Compliance and Quality
Telstar guarantees compliance with FDA requirements and provides a quality plan for validation. The ovens achieve temperature uniformity better than ±5°C at 250°C, adhering to USP standards.
Options and Accessories
The document lists additional options such as cooling designs, temperature probes, data registering devices, loading accessories, and SCADA control systems. Various models are available, each with specific dimensions and weights, ranging from PM 350 to PM 5000.
Contact Information
For further inquiries, Telstar can be contacted via email at [email protected] or through their headquarters and factory locations in Spain, and their North America office in the USA.
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Catalog excerpts

Pyromega-1

Technical data Control systems The unit is PLC controlled, which contains the operating software and parameters for creating and storing recipes or cycles. The control panel features: Inner chamber dimmensions Chamber Volume Overall dimmensions Approximate Weight • Push buttons: Open/close door, alarm acknowledgement. • Graphic register. • Colour touch-screen that displays the main functions and performs as humanmachine interface (HMI). • Control lights: Locked doors, alarm, cycle running, end of cycle. The supervisory and control system has two versions: Please contact [email protected] for further information. The MicroSter® is the simplest version, accurate and easy to use, ideal for research laboratories, quality control and auxiliary service equipment. This version includes a thermal printer for recording main events and parameters of the cycle: Operator identification, Batch No., Batch description, Cycle parameters, readings, etc. SCADA PharmaSter Options and accessories Cooling design by integrating a water heat exchanger, or by air renewal. Additional temperature probes. Additional data registering devices in standard graphic register. Loading accessories: loading carts, trolleys, trays, etc. Complete panelling. Maintenance access door. SCADA control systems, 21 CFR Part 11 compliant. This system includes a PC and TFT colour display. The hardware and software package solution allows not only for supervision and control of the process, but also compiling, storing and processing the whole information in a batch oriented mode. The system is fully compliant with 21 CFR Part 11 guidelines. Headquarters Av. Font i Sagué, 55 Parc Científic i Tecnològic Orbital 40 08227 Terrassa (Spain) T +34 937 361 600 F +34 937 861 380 Factory Pol. Ind. El Congost Avda. Sant Julià, 260, Nau K 08403 Granollers (Spain) T +34 938 492 300 F +34 938 405 337 www.telstar-lifesciences.com BR-PYROMEGA-EN-1210 Telstar reserves the right to improvements and specifications changes without notice. PyroMega Dry Heat Depyrogenising Ovens

 Open the catalog to page 1
Pyromega-2

Design & construction features Durability, Ease of Maintenance A choice of quality Telstar represents nowadays one of the most advanced and quality alternatives worldwide in the field of sterilisation equipment under cGMP guidelines. Engineering and manufacturing practices follow ISO 9001 procedures, USP and EU pharmacopoeias, GAMP guidelines, etc. Our aim is to make your validation faster, easier and efficient for you. To ensure the equipment meets your requirements, we work in partnership with you and a dedicated team follows your order as a unique project. We develop specific Quality Plan...

 Open the catalog to page 2
Pyromega-3

Design & construction features Durability, Ease of Maintenance A choice of quality Telstar represents nowadays one of the most advanced and quality alternatives worldwide in the field of sterilisation equipment under cGMP guidelines. Engineering and manufacturing practices follow ISO 9001 procedures, USP and EU pharmacopoeias, GAMP guidelines, etc. Our aim is to make your validation faster, easier and efficient for you. To ensure the equipment meets your requirements, we work in partnership with you and a dedicated team follows your order as a unique project. We develop specific Quality Plan...

 Open the catalog to page 3
Pyromega-4

Design & construction features Durability, Ease of Maintenance A choice of quality Telstar represents nowadays one of the most advanced and quality alternatives worldwide in the field of sterilisation equipment under cGMP guidelines. Engineering and manufacturing practices follow ISO 9001 procedures, USP and EU pharmacopoeias, GAMP guidelines, etc. Our aim is to make your validation faster, easier and efficient for you. To ensure the equipment meets your requirements, we work in partnership with you and a dedicated team follows your order as a unique project. We develop specific Quality Plan...

 Open the catalog to page 4
Pyromega-5

Technical data Control systems The unit is PLC controlled, which contains the operating software and parameters for creating and storing recipes or cycles. The control panel features: Inner chamber dimmensions Chamber Volume Overall dimmensions Approximate Weight • Push buttons: Open/close door, alarm acknowledgement. • Graphic register. • Colour touch-screen that displays the main functions and performs as humanmachine interface (HMI). • Control lights: Locked doors, alarm, cycle running, end of cycle. The supervisory and control system has two versions: Please contact [email protected] for...

 Open the catalog to page 5
Pyromega-6

Technical data Control systems The unit is PLC controlled, which contains the operating software and parameters for creating and storing recipes or cycles. The control panel features: Inner chamber dimmensions Chamber Volume Overall dimmensions Approximate Weight • Push buttons: Open/close door, alarm acknowledgement. • Graphic register. • Colour touch-screen that displays the main functions and performs as humanmachine interface (HMI). • Control lights: Locked doors, alarm, cycle running, end of cycle. The supervisory and control system has two versions: Please contact [email protected] for...

 Open the catalog to page 6

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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.