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Best Practices for Medical Converting: Clean Room Manufacturing and Processing Converted Parts

In the vital field of medical converting, achieving the highest standards of cleanliness and precision in the manufacturing process is paramount. Understanding the role and impact of optimizing clean room practices on your products is essential. 

This article will provide you with an in-depth understanding of the essential components of clean room manufacturing and how they contribute to maintaining product integrity for medical converting. From advanced HEPA filtration systems to stringent operator protocols, we cover the key elements that ensure a contamination-free environment. Optimizing clean room practices is crucial for the safety and compliance of medical product manufacturing.

Moreover, you’ll learn about PLITEK®‘s meticulous handling processes for transforming materials within clean rooms meeting the highest standards. By the end, you’ll have a clear understanding of clean rooms, how they work, and their benefit at PLITEK®.

The Importance of Clean Rooms in PLITEK®‘s Medical Converting Process

At PLITEK®, our commitment to serving the medical marketplace is displayed through our investment in Class 8 clean room manufacturing facilities as a crucial part of our manufacturing process. The integration of clean rooms is not just a feature; it’s a strategic decision driven by our market focus and the needs of our customers in the medical sector.

Why is Optimizing Clean Room Practices Essential for Medical Converting

  • Ensuring Product Purity and Safety: In medical converting, the cleanliness, purity, and safety of manufactured products are paramount. Clean rooms provide a controlled environment significantly reducing the risk of contamination from particulates. These environments ensure the products we manufacture meet the stringent standards required for medical applications.
  • Compliance with Industry Standards: The use of clean rooms is essential for compliance with industry regulations and standards. These controlled environments are designed to meet specific cleanliness levels as required in the production of medical devices and components.
  • Investment in Quality: Our investment in clean room technology underscores our commitment to delivering the highest quality products. The commitment reflects our dedication to meeting the specific needs of the medical marketplace. The margin for error is minimal and the demand for precision and reliability is at its highest.

Key Elements of a Clean Room for Medical Converting

In medical converting, the role of a clean room cannot be overstated. At PLITEK®, we recognize the critical importance of maintaining the highest standards of cleanliness and contamination control. Here are some of the essential aspects of a clean room that we prioritize:

  • HEPA Filters and Positive Airflow: HEPA (High-Efficiency Particulate Air) filters are crucial in a clean room environment. They effectively trap particles as small as 0.3 microns with a 99.97% efficiency, ensuring that the air within the clean room remains free of contaminants.
    • Positive airflow plays a vital role in maintaining a contamination-free environment. This system pushes out or filters any particulate matter effectively, maintaining the integrity of the clean room.
  • Operator Wearables: The attire of operators in a clean room is meticulously regulated to prevent any contamination from human sources. This includes wearables like hairnets, masks, non-shedding jackets, and booties to cover shoes. Each piece of clothing is designed to minimize the release of fibers or particles into the clean room environment.
  • Tacky Mats: Tacky mats are placed at the entrances of clean rooms. The mats are adhesive-coated to capture dirt and particles from the soles of shoes or wheels before entering the clean area. The mats thereby reduce the risk of contamination.
  • Changing Room Protocols: A changing room is an essential transitional space where operators prepare to enter the clean room. This preparation involves specific procedures to ensure that operators are properly gowned and that any contaminants from outside are not carried into the clean room. 

PLITEK®‘s Primary Objective for Medical Converting – Clean Room Manufacturing

Our primary intent for medical converting is incorporating clean rooms into our manufacturing process centered around the concept of minimization – specifically, minimizing the risk of particulate contamination in the products we deliver to our customers. This focus is crucial, especially considering the nature of the materials we handle and the stringent requirements of our clients.

Minimizing Contamination Risks:

  • Handling Non-Clean Room Materials: Some raw materials specified by our customers we receive are not produced in clean room environments. Our challenge and focus are on how we handle these materials to significantly reduce the chance of introducing any particulate or contamination to the final product.
  • Control Measures in Clean Rooms: To achieve this, we employ various control measures within our clean rooms. For instance, we might use web cleaners to treat materials that were made outside of a clean room. These cleaners, both contact and non-contact types, break the static barrier of the material and remove particulate matter effectively.
  • Custom Extrusion in Clean Rooms: Another approach we take is to produce certain materials in-house, using our Class 8 Clean Room custom extrusion capabilities within a clean room. This process ensures that the materials are clean room grade from the start, further enhancing the cleanliness and quality of the final product.
  • Enhancing Product Value: By converting non clean room materials into clean room grade products and offering in-house clean room extrusion, we not only meet but exceed the cleanliness standards expected by our clients. This approach adds significant value to the products, making them more suitable for sensitive applications, especially in the medical field.

Essential Packaging Considerations for Medical Converting

In medical converting, the packaging and handling of materials is as crucial as the manufacturing process itself. There are specific packaging variables that we meticulously manage to ensure the integrity of materials within a clean room setting. 

Key Packaging Considerations:

  • Double Bagging of Materials: One of the primary packaging protocols we implement is double bagging. This is especially important for materials sourced from outside suppliers. The outer bag, which is more likely to have been exposed to contaminants, is removed in a changing room before the material enters the clean room. This process significantly reduces the risk of introducing particulates from the external environment into the clean room.
  • Handling the Inner Bag: Inside the outer bag is a clean inner bag that contains the actual material. Once in the clean room, this inner bag is carefully removed, and the material is extracted for use. The inner bag is then disposed of immediately to maintain the cleanliness of the environment.
  • Specification of Core Materials: The type of core on which materials are wound is another critical factor. Within the medical industry, plastic cores are typically the choice over fiber cores. We mandate the use of plastic cores as they do not shed particles like paper or fiber cores, which can significantly increase particulate counts in a clean room.
  • Avoidance of Paper Products: Paper products are generally avoided in clean room environments due to their propensity to release particles. Simple actions like flipping a piece of paper can cause a noticeable increase in particle counts, which is unacceptable in a clean room setting.

Medical Converting – Measuring Particulates in Clean Rooms

Ensuring the cleanliness of our clean rooms is a critical aspect of our manufacturing process. Strict measures are in place particularly when it comes to controlling particulate matter. Understanding and measuring particulate levels is essential to maintaining the high standards required in these controlled environments. 

Measuring Particulates in Clean Rooms:

  • Use of Particle Counters: To accurately measure particulate matter, we use a device known as a particulate counter. This instrument is crucial for detecting and quantifying the number of particles in the air. The device alerts to particles even too small to be seen with the naked eye.
  • Adhering to ISO Class 8 Standards: Our clean rooms operate under the ISO Class 8 classification. This standard specifies the allowable particle count limits for different particle sizes, specifically for particles that are half a micron and five microns in size.
  • Regular Monitoring to Stay Within Limits: The primary goal in our clean rooms is to ensure that the number of particles does not exceed the specified limits for these sizes. Regular monitoring using particle counters helps us maintain the required cleanliness levels consistently.
  • Extensive Clean Room Facilities: Across PLITEK®, we have nine clean rooms predominantly used in our rotary die cutting departments and all our extrusion capabilities. Each of these clean rooms adheres to the same stringent standards to ensure uniformity in cleanliness and quality across our operations.
  • Ensuring Product Integrity: By rigorously measuring and controlling particulate levels, we ensure that the products manufactured in clean room environments meet the high-quality standards required, especially for medical applications where cleanliness is paramount.