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Medical & Healthcare Thermal & Environmental Solutions | Tempo Instruments (BriskHeat Style)
ISO 13485:2016 Certified

Precision Thermal Heating & Environmental Control For Medical & Life Sciences

Engineered specifically for biological storage, pharmaceutical drug stability, cleanroom depyrogenation, and medical device manufacturing. Built to exceed FDA 21 CFR Part 11, USP Class VI, and ISO 13485 standards.

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✓ 21 CFR Part 11 Audit Trail
✓ Class 100 / ISO 5 Cleanroom
✓ USP Class VI Silicone

Medical Thermal Advisor

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BriskHeat Style
Matched Solution:
TI-STAB-HC Pharma Stability Test Chamber
Built for Life Sciences

Medical & Healthcare Thermal Solutions

Tempo Instruments manufactures heavy-duty heating, drying, stability testing, and storage systems adhering to international healthcare and laboratory regulations.

01

Pharma Drug Stability

Precise climate testing under ICH Q1A guidelines with full 21 CFR Part 11 electronic data logs and audit trails.

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02

Cleanroom Sterilization

Dry heat depyrogenation ovens with HEPA filtration for sterilizing glassware, surgical instruments, and medical devices.

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03

Device & Catheter Heating

Flexible USP Class VI silicone heating jackets engineered for medical tubing extrusion, curing, and bioprocess vessel heating.

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04

Blood & Vaccine Storage

Strict +4°C whole blood storage refrigerators and ultralow cold storage cabinets with dual alarm safety monitoring.

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Healthcare & Medical Product Line

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FDA Compliant
SKU: TI-STAB-HC
21 CFR Part 11

Pharmaceutical Stability Test Chamber

Controlled climate testing chamber built for pharmaceutical shelf-life stability according to ICH Q1A guidelines with continuous electronic audit logging.

Temperature Range: 10°C to 60°C (± 0.2°C)
Humidity Control: 20% to 98% RH (± 2%)
Chamber Material: SS 316L Mirror Finished
Class 100 / ISO 5
SKU: TI-DSO-MED
Depyrogenation

Cleanroom Depyrogenation Oven

High-temperature dry heat sterilizer engineered to eliminate bacterial endotoxins on medical glassware, vials, and surgical implants at up to 300°C.

Max Sterilize Temp: 300°C High Uniformity
Filtration System: High-Temp HEPA Class 100
Exhaust System: Forced Air Damper Control
FlexoMed™
SKU: TI-FMHJ-MED
USP Class VI

Medical Grade Silicone Heating Jackets

Custom-contoured surface heating jackets constructed from medical-grade USP Class VI silicone for catheter curing and bioprocess vessel heating.

Material Standard: USP Class VI & FDA Silicone
Max Operating Temp: 232°C Continuous
Integrated Sensor: Pt100 RTD / Thermocouple
Biological
SKU: TI-INC-BIO
GMP Grade

Bacteriological & CO2 Incubator

Precision bacteriological and CO2 incubators for cell culture growth and microbiological safety testing with anti-microbial internal coating.

Temperature Range: Amb +5°C to 70°C (±0.1°C)
CO2 Control: 0-20% IR Dual Beam NDIR
Decontamination: 180°C Dry Heat Cycle
Blood Storage
SKU: TI-BPC-400
ISO 13485

Blood Bank & Plasma Cabinet

Medical refrigerator designed for precise +4°C whole blood storage with battery backup, circular chart recorders, and dual temp probe monitoring.

Storage Temperature: Strict 4°C ± 0.5°C
Backup System: 72-Hour Battery Backup
Safety Features: Audio/Visual Auto Alarm
Drying Oven
SKU: TI-CLO-200
Cleanroom

Medical Cleanroom Convection Oven

Heavy-duty cleanroom oven for drying washed surgical trays, implants, and catheter components post-sanitization with zero particle generation.

Airflow System: Laminar Forced Convection
Operating Range: 50°C to 250°C
Construction: 316L Stainless Interior
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Recommended Equipment Model

TI-STAB-HC Stability Chamber

Full 21 CFR Part 11 software compliance with ICH Q1A temperature and humidity mapping.

Technical Reference

Equipment Specifications Matrix

Model Series Primary Application Operating Temp Range Key Certification Action
TI-STAB-HC Pharma Drug Stability Testing 10°C to 60°C (20-98% RH) 21 CFR Part 11
TI-DSO-MED Dry Heat Depyrogenation Oven Ambient to 300°C Class 100 / ISO 5
TI-FMHJ-MED Silicone Catheter & Tubing Heating Up to 232°C Continuous USP Class VI
TI-INC-BIO Cell Culture & Microbiology Amb +5°C to 70°C GMP Grade
TI-BPC-400 Whole Blood Storage Cabinet Strict +4°C (±0.5°C) ISO 13485:2016

Quality Assurance & Compliance Guarantee

All Tempo Healthcare equipment is manufactured under ISO 13485 quality systems and validated for FDA 21 CFR Part 11 protocols.

ISO 13485:2016 FDA 21 CFR Part 11 USP Class VI CE Certified
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