Specifically calibrated for high-volume clinical autoclaves operating in São Paulo healthcare systems.
As the primary healthcare hub of Latin America, the metropolitan area of São Paulo hosts some of the continent's most sophisticated clinical institutions, including Hospital das Clínicas, Albert Einstein, and Sírio-Libanês. Operating in this high-density healthcare market requires compliance with local regulatory frameworks, primarily mandated by the Brazilian National Health Surveillance Agency (ANVISA) under the resolution RDC 15/2012.
Our Bowie-Dick Test Packs serve as an indispensable verification system in Central Sterile Supply Departments (CSSDs/CMEs) across São Paulo. Designed to identify air leaks, inadequate steam penetration, and non-condensable gases (NCGs) in pre-vacuum steam sterilizers, these packs guarantee that critical surgical instrumentation is exposed to proper sterile conditions before operations.
Mandatory daily air-removal validation for pre-vacuum steam systems.
Conforms to rigorous global standards for Class 2 chemical indicators.
Guangdong Onyx Medical Co., Ltd. is a leading national high-tech enterprise specializing in the research, development, production, and supply of advanced materials for the personal care, medical, and electronics industries. Since its establishment, the company has adhered to a core philosophy of innovation and quality, dedicated to providing high-quality products and solutions to customers worldwide.
Located in Guangdong, China, the company operates a modern manufacturing facility covering over 60,000 square meters, equipped with three Class 100,000 cleanrooms and more than 30 PLC-controlled automated production lines. This state-of-the-art infrastructure ensures that every production process meets the highest levels of precision and safety, adhering to international standards.
Guangdong Onyx Medical operates under the guiding principles of "Technological Innovation, Quality First," striving to establish a strong brand presence in the global market. The company places a strong emphasis on quality control while ensuring that its production processes are sustainable. With a commitment to environmental protection, resource utilization, and social responsibility, Onyx Medical has gained a reputation as a trusted partner in the healthcare, personal care, and electronics industries.
Addressing the unique and evolving needs of global B2B medical, electronic, and personal care markets.
Developing advanced biomaterials and medical sensors widely used across diagnostic equipment, vital signs monitoring systems, and infection control processes. Dedicated to enhancing patient outcomes.
Providing high-quality component materials for personal care products, particularly infant diaper and hygiene markets, ensuring superior comfort, safety, and moisture absorption.
Manufacturing high-precision sensors and control consumables that enhance reliability in critical medical devices, offering technical validation for hospital sterilizers.
Leading R&D in biocompatible materials focused on regenerative medicine, advanced wound dressings, and drug delivery systems that push boundaries in medical sciences.
Developing next-generation substrate and interface materials for microelectronics and industrial applications, delivering high thermal stability and reliability.
Explore our visual documentation of high-capacity production lines and sterilized output systems.
Continuous automated inspection ensures zero defect outputs in every indicator sheet configuration shipped to São Paulo and global markets.
Understand the precise performance thresholds required under ISO 11140-4 compared to standard hospital monitoring protocols.
| Performance Criteria | ISO 11140-4 Requirement | Onyx Bowie-Dick Test Pack Spec | ANVISA RDC 15 Clinical Significance |
|---|---|---|---|
| Pre-Vacuum Phase Defect Detection | Sensitive to 1.5°C variations or NCG injection. | Immediate non-uniform color change in central zone. | Ensures no cold air pockets remain in the autoclave chamber. |
| Saturated Steam Exposure | 134°C (3.5 min) or 121°C (15 min). | Calibrated precisely for standard 3.5 min and 4 min steam cycles. | Exposes sub-optimal sterilization parameters in Brazilian hospitals. |
| Indicator Ink Safety | Preferably organic solvent and heavy metal free. | 100% Water-based, Lead-free, and Non-toxic chemical ink. | Aligns with Brazilian local environmental laws (CONAMA). |
| Archivability of Result | No significant color fade within 12 months. | Stable for at least 5 years under standard dark storage conditions. | Conforms to hospital legal medical record archive rules (5+ years). |
Verifies that the vacuum pump successfully extracts air from porous loads, preventing micro-bubbles that block heat contact.
Identifies minimal non-condensable gas proportions that can lead to local sterilization failures in deep tube-like surgical lumens.
Certified internationally to fulfill both European Standards (EN 867-4) and Global Quality Frameworks (ISO 11140).
Addressing core technical, regulatory, and logistics queries from clinical purchasing teams in São Paulo.
ANVISA RDC 15/2012 dictates that autoclaves equipped with pre-vacuum cycles must undergo daily air removal testing before initiating routine sterilizer runs. Our test packs act as the required Class 2 chemical indicator test system, ensuring your CSSD complies with local surveillance audits.
A successful cycle is indicated by a uniform color shift from yellow to dark green/black across the entire sheet. A failure is detected when the center remains light, showing spotty patches or uneven color transitions, which signals NCG entrapment, low quality steam, or door seal leaks.
As a global manufacturer, Onyx Medical regularly coordinates B2B supply lines directly to the Port of Santos and Guarulhos Airport. We provide comprehensive MSDS sheets, ISO certifications, and detailed customs declarations to guarantee smooth clearance processes for Brazilian importers and distributors.
No, all Onyx-produced Bowie-Dick test indicators are manufactured using advanced water-based, lead-free indicator chemistry. They pose no health risks to CSSD operators and do not require specialized hazardous waste management under Brazilian local legislation.
Explore the complete range of autoclave monitoring indicators and sterilization consumables manufactured for industrial distributors.
Partner with Guangdong Onyx Medical Co., Ltd. to access high-quality infection control consumables under direct manufacturing agreements. Custom packaging, bulk pricing discounts, and complete regulatory compliance papers are available upon request.
Send Inquiry Now
Onyx Medical