The construction of the 100000 level purification workshop in Meidi Medical Phase II is underway

——Support stable quality and scale delivery of medical nursing tissue with a more controllable production environment
In response to the higher requirements for cleanliness, stability, and traceable delivery of paper products in medical care and professional cleaning scenarios, the Meidi Medical Phase II project is constructing a 100000 level purification workshop. This project will further enhance the environmental control capabilities of medical nursing tissue and related products in the production, conversion, and packaging processes, providing a more stable, auditable, and replicable supply foundation for B2B customers.

What is a 100000 level purification workshop?

The term '100000 level' usually corresponds to the air cleanliness level of Class 100000 (approximately equivalent to ISO 8), and its core meaning is to quantitatively control suspended particles in the air.
Taking the FDA's table on clean area air levels as an example, in Class 100000/ISO 8 environments, the concentration limit for particles ≥ 0.5 µ m is 3520000 particles/cubic meter (corresponding to the expression "0.5 µ m particles/cubic foot=100000"). U.S. Food and Drug Administration
Purification workshops usually achieve "controllability" through the following systems:
-Filtering and return air system (such as HEPA)
-Reasonable ventilation frequency, airflow organization, and pressure difference zoning (FDA also mentioned that ISO 8 support zones typically have at least about 20 air changes per hour as a typical reference)
-SOP for Personnel/Material Separation, Clean Changing and Disinfection
-Environmental monitoring and recording (particles/microorganisms, etc., established according to product positioning and customer requirements)
Important note: The value of a purification workshop lies in reducing pollution risks and improving consistency; It itself is not equivalent to 'sterile'. If the customer's requirements involve sterilization/aseptic delivery, a validated sterilization process and packaging system need to be provided separately.

Why do we need to do it? (From the perspective of B-end customers' concerns: customer complaints, factory audits, stability, costs)

For B2B customers, the real factors that affect long-term cooperation are often not "single sample performance", but batch consistency, customer complaint rate, factory approval rate, and long-term delivery stability. The core purpose of building a 100000 level purification workshop is to make these variables more controllable and verifiable.
1) Reduce the uncertainty caused by "dust/debris/environmental particles" in paper products
Medical care tissues, wiping papers, face towels and other products are often more sensitive to "cleanliness" and "residual particles" during use. The FDA also pointed out that particles in the air may not only enter products as foreign pollutants, but may also become carriers of biological pollution. U.S. Food and Drug Administration
A cleaner and more controllable environment helps reduce external particle interference in production and packaging processes, resulting in more stable performance of finished products.
2) Make microbiology and cleanliness management more quantifiable and compatible
Many channels (medical beauty institutions, nursing channels, professional distributors, cross-border platforms) require cleanliness, microbiological indicators, or corresponding quality inspection data when importing products.
After the construction of the purification workshop, the relevant environmental control and monitoring can be more systematic, making it easier to coordinate with customers' factory inspection, inspection, and data requirements.
3) Improving production consistency and yield is more conducive to long-term cost control
Temperature and humidity, air cleanliness, and stable on-site management can often improve fluctuations in the conversion and packaging processes (such as rework rates, foreign object risks, packaging cleanliness fluctuations, etc.). For procurement, this means fewer anomalies, more stable quality, and more controllable overall costs.
4) Laying the foundation for large-scale supply and OEM/ODM cooperation
For customers who specialize in their own brand/channel, whether the supplier has the production conditions of "scalable, replicable, and auditable" will directly affect the cooperation limit. The second phase of the 100000 level purification workshop is essentially an investment in "scale delivery capability": when the market is in high demand, delivery is more guaranteed.

The benefits of the medical care tissue industry (industry level: from "usable" to "controllable and auditable")

The construction of a 100000 level purification workshop has a positive significance for the industry in that:
-Raise the industry's basic threshold: transform "cleanliness and process control" from a slogan to a verifiable indicator
-Promote the penetration of products into high standard scenarios: more suitable for the quality stability requirements of medical beauty/nursing institutions and professional channels
-Reducing supply chain uncertainty: helps to reduce batch fluctuations and trigger points for problems during transportation/warehousing, and ultimately lowers customer complaints and after-sales costs in the long run
-Promoting standardization and branding: For customers who wish to achieve brand premium and cross-border compliance, the 'auditable factory process capability' is a key asset

How will we collaborate with customers (what can you get)

During the progress of the second phase project, Meidi Medical can provide partners with:
-Synchronization of stage information between production line and environmental control capability (for internal review by customers)
-Prototype and specification docking for OEM/ODM projects (confirmed according to customer standards)
-Support customer factory audit/quality coordination (according to both parties' processes and compliance requirements)

Collaboration and Consulting

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