Advasaf

06/25/2025

🚀 We’re Export Ready!

Advasaf is proud to share that our team has successfully completed the ExporTech™ program—a nationally recognized export acceleration system led by Wisconsin Economic Development Corporation , WMEP Manufacturing Solutions , Wisconsin SBDC at UW-Madison , and the .S commercial service.

This milestone not only strengthens our commitment to quality and compliance, but also expands Advasaf’s capabilities in global medical device distribution and private-label manufacturing.

From hands-on coaching to market entry strategies, the support we received through ExporTech has equipped us to build strong international partnerships and grow Wisconsin exports globally.

A huge thank you to the dedicated professionals who made this possible:
🔹 Baichoo – WMEP Manufacturing Solutions
🔹 Grube – U.S. Commercial Service, Wisconsin
🔹 L. -Duszynski – U.S. Commercial Service
🔹 Wojtowicz EJD LCB CGBP – SBDC Wisconsin
🔹 WEDC Export Team

We’re excited for what’s next — building trust, enabling growth, and expanding access to high-quality, American-made medical solutions.

🌎

12/14/2024

We are thrilled to announce that Advasaf LLC has been officially certified by the FDA as a small business under the Medical Device User Fee Amendments (MDUFA) program for Fiscal Year 2025! 🎉

This milestone is not just a recognition of our commitment to excellence but also an opportunity to bring even more value to our partners in the medical device industry.

With this certification, Advasaf is uniquely positioned to:
✅ Streamline FDA submissions for medical devices, helping accelerate time-to-market.
✅ Provide cost-effective manufacturing, sterilization, and packaging solutions tailored to your needs.
✅ Ensure regulatory compliance and traceability, making the process seamless and efficient.

As an FDA-registered and women- and minority-owned small business, we are proud to support innovation and diversity in the healthcare industry.

💡 If your company is looking for a reliable partner to assist with medical device manufacturing, sterilization, or regulatory submissions, let’s connect! We would love to collaborate and explore how Advasaf LLC can help you achieve your goals.

📩 Feel free to message me directly or email us at kashyap@advasaf.com. Let’s shape the future of healthcare together!

11/13/2024

Visit from our friends to get an understanding of our capabilities

10/12/2024

Advasaf dvasaf is excited to be part of the Advanced Manufacturing Expo in Minneapolis! We look forward to engaging with both our current partners and new clients in the medical device industry. As a leader in sterilization and contract manufacturing, we are dedicated to ensuring the highest standards of safety and efficiency. This event provides a great opportunity to showcase our innovative solutions and explore future collaborations. Exciting days ahead!

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01/30/2024

Glad to support Youth Cricket Wisconsin Cricket Wisconsin and promote youth sports in the community.

With a fast paced 2023, for all things cricket, the summary of our updates include several achievements. Our participants, sponsors, volunteers and organizers are our key stake holders. Gratitude to our Sponsors All of these wouldn't be possible with the support of key sponsors in big and small ways...

11/27/2023

An Advasaf production

10/31/2023

The importance of control cannot be overstated. This is expensive for companies and disruptive to the consumers.

Eye Drop Recall

09/06/2023

Proud of our continued support to local sports.

Our next sponsor of the day for Team YCW Ravens is Kashyap Malkan from Advasaf LLC.

Advasaf is an new high-tech venture in the medical device sterilization and manufacturing space that originated with local collaboration in Wisconsin. Advasaf believes having the support of the local community and growth in youth sports, helps keep talent and technology local to our community. They are very happy to support the women's league and bring cricket to the masses.

For more information, please head to their website: https://www.advasaf.com/

08/26/2023

08/23/2023

Advasaf LLC stands strong as a beacon of inclusivity and community empowerment. 💪 Embracing diversity, we champion the potential it brings for innovation and adaptability. Our commitment to Youth Cricket Wisconsin showcases our dedication to local youth sports, fostering teamwork and personal development in our town. Let's unite for a brighter, more inclusive future! 🤝🏏

Advasaf LLC stands strong as a beacon of inclusivity and community empowerment. 💪 Embracing diversity, we champion the potential it brings for innovation and adaptability. Our commitment to "Youth Cricket Wisconsin" showcases our dedication to local youth sports, fostering teamwork and personal d...

08/23/2023

Currently there are challenges with sterilization, especially around the favorites, Ethylene Oxide and Gamma. EO being impacted by ongoing EPA challenges and Gamma irradiation that has had cobalt shortages. These continue to cause capacity issues.

But what if there was a better solution?

We ideally want - cheap, available, no residuals, effective and short turn times?

Remember Steam (Moist heat) - it's still available.

Let's compare - it's really effective for sure. Since it is just heated water so we know there are no residual issues, cycles can be between 35 minutes and a couple of hours.

Considerations?

+Products need to be capable of exposure to higher temperatures… 121°C to 134°C.
+Packaging needs to be porous - relatively cost effective and available materials.
+It's so common - there is a standard ISO 17665 just for this process!
+Perceived that product can come out wet - this is largely a myth with the right cycle product comes out dry.

Maybe it's worth a look?

…. Full blog and details are available at www.advasaf.com/blog

Currently there are challenges with sterilization modalities, Ethylene Oxide and Gamma. So we can have cheap, available, no residuals, effective and short turn times sterilization? Steam (Moist heat) - is still available!

08/10/2023

The top FAQ during our intro conversation is related to getting started in sterilization and what to do.

Navigating how to produce a sterile product can be seen as a challenging process but let's break it down into steps:

1. Modality/Method Choice - the product materials your device is made out of often indicates the best method to use.
2. Packaging must be compatible with the sterilization method.
3. Product labeling will often change depending on the sterilization method used.
4. Contract Sterilizer selection, qualification, registration (FDA), commercial agreements would be the next step.
5. Methods to be used for Validation of the sterilization process can then be established.
6. Shelf Life claims determination (applicable to medical devices).
7. Regulatory submissions and approvals.

https://www.advasaf.com/post/how-do-i-do-it-starting-to-think-about-sterilization

Navigating how to produce a sterile product can be seen as a challenging process but let's break it down into steps for your consideration. Some of these items may be done in parallel (e.g. selection of sterilization provider along with packaging definitions). While the sterilization aspires to be p...