Menstrual Cup and A Personal Story.

About six years ago, I made a decision that would completely transform how I experience my periods. At that time, conversations around women’s menstrual health were just beginning to gain attention. And today organizations are introducing "menstrual leave" policies, launching healthcare awareness initiatives, and distributing pads—important steps, certainly, but only addressing a part of a much larger issue.

The pivotal moment for me came when I was 19. I remember scrolling through Instagram, as teenagers often do, when I stumbled upon a friend’s post about "sustainable periods." At the time, menstrual cups were just beginning to make waves in the West. The concept intrigued me. Imagine having a period without the constant fear of spills, leaks, or interrupted sleep! The idea was too appealing to ignore, and my curiosity got the best of me, so I ordered my first menstrual cup.

My initial experience was far from smooth sailing. There were moments of frustration and pure irritation, but the thought of going back to pads, with all their inconveniences, just wasn’t an option. So, I persisted. It took about 3-4 months before the menstrual cup and I became friends. But once we did, there was no turning back.

Since that time, I haven’t used a single pad. The menstrual cup didn’t just change my periods, it changed my life, and that is not an exaggeration. Suddenly, activities that once felt impossible during my period were now doable! Swimming, working long hours, even spending time at the barn as an equestrian, all of these became stress-free. The cup gave me a level of freedom and confidence that pads simply couldn’t match.

It was through this process that I realized I wanted to do more than just be a user—I wanted to be an advocate.

It was in 2019, when I started working with the Ami Polymer team. Together, we took on the challenge to develop our own menstrual cup, Imasafe? . By 2020, we successfully launched Imasafe? . We created a menstrual cup that embodies the values of safety, comfort, and reliability—everything that I, and so many other women, had been searching for.

What Goes Into Making an Imasafe? Menstrual Cup?

At Ami Polymer, the production of the Imasafe? menstrual cup is a meticulous process that prioritizes safety and quality. Our commitment to excellence starts with the careful selection of 100% medical-grade liquid silicone rubber, ensuring the cup is both durable and safe for long-term use. Imasafe? menstrual cup is manufactured in an ISO Class VII Cleanroom manufacturing facility.?

In manufacturing the Imasafe? menstrual cup, we specifically choose materials that are renowned for their safety and suitability for internal use. Among the most commonly used materials in the production of menstrual cups are Medical-Grade Silicone (MGS), Thermoplastic Elastomer (TPE), and Ethylene Vinyl Acetate (EVA). These materials are selected not only for their durability but also for their hypoallergenic properties and resistance to bacterial growth, making them ideal for intimate health products.

To ensure the utmost safety, these raw materials undergo rigorous Biological Reactivity Tests In-Vivo, which assess their performance in real-world conditions. We conduct Biocompatibility tests in accordance with ISO 10993 guidelines ensuring that the materials are safe and suitable for prolonged contact with the body.

In addition, for products requiring high levels of biocompatibility, we employ platinum curing systems with our health-grade silicones. Unlike other curing methods, platinum-cured silicones do not produce by-products, thereby eliminating the need for post-curing. This results in a purer, safer product, making it an ideal choice for menstrual cups like Imasafe? .

A Caveat Emptor for Women!

Did you know that under the Drugs and Cosmetics Act (DCA), menstrual cups are classified as Class B medical devices? They require registration and licensing through the Central Drugs Standard Control Organization (CDSCO), especially following the 2020 regulation expansion that brought stricter controls for such devices.

The menstrual cup industry is regulated by several key certifications and standards that ensure products are safe for consumer use. Here’s an overview of the certifications that our Imasafe? menstrual cup meets:

• FDA 21 CFR 177.2600: This regulation by the U.S. Food and Drug Administration specifies the safe use of rubber articles intended for repeated use in food contact applications, which also applies to menstrual cups.
• ISO 10993-10: This standard tests for irritation and skin sensitization, ensuring that the cup does not cause adverse reactions when in contact with the vaginal membrane.
• ISO 13485 Certified: This certification is specific to medical devices and ensures that our menstrual cup is produced in accordance with the highest quality management standards.
• Vaginal Membrane Irritation Test: A specialized test to ensure that the menstrual cup does not irritate the delicate tissues of the vaginal ca
• ROHS Compliant: The Restriction of Hazardous Substances Directive ensures that the cup does not contain dangerous materials such as lead or mercury.
• BPA Free: Bisphenol A (BPA) is a chemical that can have adverse health effects, and our cup is guaranteed to be free from BPA.
• TSE/BSE Free: The cup is tested to ensure it does not carry Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform Encephalopathy (BSE), which are serious health risks.
• Phthalate Free: Phthalates are chemicals used to make plastics more flexible, but they can be harmful to health. Our cup is free from these chemicals.
• ISO 10993-4: This standard tests for interactions with blood, ensuring the cup is safe for use in contact with blood.
• ISO 10993-11: This standard ensures that the cup does not cause systemic toxicity when in contact with the body.
• ISO 10993-5: This standard tests for cytotoxicity, ensuring that the cup does not cause cell damage.

These certifications provide assurance that our Imasafe? menstrual cup is not only safe but also meets the highest standards of the regulatory markets.

The Journey Continues...

Since I made the switch to a menstrual cup, I've witnessed an inspiring ripple effect among the women in my life. All of my friends, after hearing about my experience, decided to try it themselves, and soon they, too, discovered the benefits of using a menstrual cup which was a more sustainable, comfortable, and empowering choice. However, I’ve also learned that encouraging women to make this transition is not always straightforward. And as the quote goes, 'old habits die screaming,' these often create barriers that are difficult to overcome.

But these are my five go-to things that I've always told women about menstrual cups:

• Healthy
• Environment- friendly
• Pocket-friendly
• Easy to carry
• last one and my favorite: elevates your lifestyle!

My own journey with the menstrual cup began out of a desire for a better solution to managing my period. But the benefits I’ve experienced have far outweighed those initial difficulties. Today, I feel a deep sense of pride in having contributed to the development of Imasafe?

Switching to a menstrual cup might seem daunting at first, but with the right support and information, it’s a change that can lead to profound positive impacts, not just for individual women, but for the environment as well. As we continue to push forward in advancing women’s health, my hope is that more women will be inspired to make the switch, just as I did, and discover the freedom, confidence, and peace of mind that come with it.

At Ami Polymer, we’re deeply committed to this mission. We understand the hesitations women may have, and that's why we dedicate ourselves to educating them about the advantages of menstrual cups, while also addressing any concerns they might have. Our goal is to empower women with accurate information and provide them with high-quality products that they can trust. We believe that every woman deserves to make informed decisions about her menstrual health, free from fear and uncertainty.

Ami Polymer Pvt. Ltd., We excel in biopharmaceutical manufacturing with these strengths:

• State-of-the-Art Manufacturing Plant: Spanning 250,000 sq. ft., including 60,000 sq. ft. of ISO Class 7 & 8 Cleanrooms.
• Workforce: Supported by a team of 600+ employees.
• Advanced Capabilities: Laser-controlled extrusion, automated hose production, thermoplastic extrusion lines, automatic hydraulic presses for elastomers and polymeric components, and in-house tooling and mold-making machinery.
• Certifications: FDA 21 CFR 177.2600, USP Class VI, ISO 10993, NSF-51, BPOG Extractable Studies, RoHS Compliance, TSE/BSE Free, and Phthalate Free.

Join us in revolutionizing the future of healthcare with cutting-edge technology and unparalleled dedication! Visit our website at www.amipolymer.com or contact us to learn more at [email protected]. ????Take a sneak-peak look at our advanced facility

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United Nations Population Fund (UNFPA) | 联合国儿童基金会 | UNICEF India | Ami Polymer Pvt. Ltd. | Imasafe? | Alpesh Gandhi | Jigisha Gandhi | Ami Polymer Pvt. Ltd. | Suresh Kumar | Darshan Gandhi | Vinay Pandey | Satish Yadav | ANUJ SINGH | Harsh Solanki | Rohit Shukla | Radhakrishna A | Ravindra Patil | Ankit Nahar | Shridhar Pandey | Jay Shah | Joel Lalucherian | Simran Singh | Shivhari Banait | Varsha Singh, M Pharm | Manisha Boga | Shubham Mishra | Sweta Jha | Manish Khatana, MBA.