Understanding Our Class-100K Cleanroom: The Pinnacle of Sterile Manufacturing

Amaryllis Healthcare manufactures products in a Class 100K cleanroom, as prescribed by international standards for ensuring strict control over airborne particles and hygiene. This controlled environment is vital to our production of high-quality medical devices and surgical solutions.

In this edition, we take a closer look at our cutting-edge Class-100K cleanroom, which plays a pivotal role in maintaining the highest standards of quality in our manufacturing processes.?

What is a Class-100K Cleanroom??        

Class-100K cleanroom, often referred to as an ISO Class 8 cleanroom, is a controlled environment where airborne particles are tightly regulated. This level of cleanliness is vital when producing medical devices and surgical products that demand highly regulated hygiene standards. Ensuring this clean and sterile environment helps us maintain the quality and safety that our clients rely on.

Our Advanced Manufacturing Facility

All Amaryllis Healthcare's products are manufactured in Class 100K cleanroom environment in India's largest manufacturing facility. Our 100,000 sqft facility houses over 500+ dedicated professionals, all working towards a single goal – to provide unmatched medical solutions. In addition to having European CE, ISO 13485, and CDSCO certification we have in-house sterilization and packaging capabilities.

Key Features -

1. Particle Count Limits:

• A Class 100,000 clean room allows up to 100,000 particles per cubic foot of air
• The particles that are measured are usually 0.5 microns in size or larger

2. Air Changes Per Hour (ACH):

• The room typically has 10-25 air changes per hour
• To eliminate airborne particles, High-Efficiency Particulate Air (HEPA) filters are utilized

3. Air Quality Standards:

• The clean room meets ISO 14644-1 standards, which classify the cleanliness levels of air based on the particle count

4. Environmental Controls:

• Temperature and humidity are closely monitored controlled and monitored
• Positive air pressure is maintained to prevent contamination from entering the room

5. Surface and Material Standards:

• Surfaces within the clean room are easy and smooth to clean
• Materials used are resistant to particle shedding Materials used are resistant to particle shedding

6. Personnel Protocols:

• Personnel must wear specialized clothing such as gowns, gloves, masks, and shoe covers to minimize contamination
• Strict procedures are followed when entering and leaving the clean room

Why is a Class-100K Cleanroom Essential?

• Infection Control: By minimizing airborne contaminants, our cleanroom significantly reduces the risk of infections, ensuring that our surgical gowns, drapes, and packs are sterile and safe for use
• Quality Assurance: The controlled environment ensures that our products consistently meet the highest quality standards, providing reliability and safety in every unit
• Regulatory Compliance: Our cleanroom complies with international standards such as ISO , European CE and CDSCO ensuring our products are globally recognized for their excellence

Key Features of Our Facility:?

• In-House Sterilization: Our products undergo Ethylene Oxide (EO) sterilization as per internationally acknowledged ISO 11135 standards, ensuring they are free from any microorganisms
• Medical-Grade Packaging: We use packing materials that meet ISO 11607-1 and EN 868-5 requirements, ensuring the sterility and integrity of our products
• ?Non-Woven Fabrics: Our materials meets the highest standard, including AAMI PB70:2003 (American) and EN13795 (European), ensuring exceptional barrier protection and comfort in our cleanroom?

Why Choose Amaryllis Healthcare?

• Proven Expertise: With over a decade of experience, we’ve been instrumental in over 10 million+ surgeries, positively impacting the lives of 100 million+ individuals
• Trusted by Professionals: Our commitment to quality and innovation has earned the trust of more than 550+ top hospitals across India.
• Continuous Innovation: We remain at the forefront of healthcare solutions, expanding our range of offerings to meet the evolving needs of the medical community

Thank you for exploring our Class-100K cleanroom and discovering how our advanced manufacturing capabilities support our mission of excellence in healthcare.        

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If you’d like to know more about our products, email us at [email protected] ? ?

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