MicroPolx® 1900 – Specifications and Advantages

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In the previous article, we examined the various ways to use microfiber wipes in healthcare and pharmaceutical environments. We also provided an overview of Berkshire’s MicroPolx® family of wipes and how the newest member, MicroPolx® 1900, integrates into your cleaning protocols. In this next installment, we will discuss MicroPolx 1900 in greater detail, highlighting its specifications, advantages, and application performance in healthcare and pharmaceutical settings.

MicroPolx® 1900 – Specifications and Advantages

Berkshire’s MicroPolx® 1900 is a leading solution that combines the exceptional cleaning capabilities of microfiber with the suitability for high-grade cleanroom environments, all at an affordable price. It was developed as a next-generation wipe to tackle both contamination control and practical cleaning challenges in pharmaceutical and healthcare settings.

Key Specifications of MicroPolx® 1900:

– Material Composition: Made from a knitted blend of 75% polyester and 25% nylon microfiber. This bi-component construction benefits from the strength and cleanliness of polyester paired with the superior absorbency of nylon. The fibers are ultra-fine (micro denier) and split to maximize surface area. The 75/25 blend improves absorbency compared to more common 80/20 microfiber textiles while still maintaining excellent fiber integrity. Each yarn’s wedge-shaped polyester and nylon filaments increase the surface area and enhance wiping efficiency.

– Edge Type: The edges are laser-cut and sealed to prevent fiber release. The laser sealing creates a smooth, non-abrasive border with minimal lint. Sealed edges are crucial for avoiding loose threads during critical cleaning, a feature that meets or exceeds industry standard practices. Compared to competitor microfiber wipes Berkshire’s laser sealing is highly precise and contributes to the wipe’s ultra-low particle count.

– Cleanroom Laundering and Packaging: These wipes are laundered in an ISO Class 5 (Class 100) cleanroom and packaged in a double-bagged format for cleanroom entry. By laundering in a Class 5 environment, Berkshire ensures that the wipes are free from contaminants at a level appropriate for pharmaceutical Grade A/B (ISO 5) use. Each lot includes documentation (certificate of conformance) to verify particle and fiber counts. The final product is suitable for use in environments rated from ISO 5 to ISO 8 without risking contamination.

– Wipe Size and Format: Available in convenient sizes of 9″x9″ and 12″x12″, with 100 wipes per pack (10 packs per case for bulk purchases). This sizing is standard for cleanroom wipes, providing a large surface area for effective cleaning. The wipes are typically quarter folded in their packaging for ease of use, allowing technicians to utilize a folded wipe and then refold it to expose clean surfaces. The packaging is designed for cleanroom introduction, typically double poly bagged.

– ISO and GMP Suitability: Rated for use in ISO Class 5 cleanrooms and higher classes. In terms of Good Manufacturing Practice (GMP), this standard covers Grade A/B backgrounds (ISO 5) and is also suitable for Grade C (ISO 7) and Grade D (ISO 8) areas.

Berkshire MicroPolx® 1900 cleanroom microfiber wipes different sizes are designed for optimal performance in controlled environments. These wipes feature laser-sealed edges and a smooth, non-shedding surface, making them essential for use in ISO Class 5 to 8 cleanrooms. 

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Performance Advantages in Healthcare and Pharmaceutical Applications:

MicroPolx 1900 offers several benefits that set it apart from standard wipes:

  1. Exceptional Cleaning Efficacy: The microfiber construction ensures superior removal of dust, active pharmaceutical ingredients, and bacteria without damaging surfaces. This leads to visibly cleaner surfaces and reduces microbial loads, which are essential before sanitization or sterile operations.
  2. Reduced Aggressive Cleaners: With its high sorptive capacity, MicroPolx® 1900 can clean effectively with less solvent than traditional wipers. It efficiently lifts oils and residues, demonstrating a better performance compared to standard wipes, which reduces costs and environmental impact.
  3. Surface-Safe and Non-Abrasive: The smooth, knitted microfiber won’t scratch delicate surfaces, ensuring the integrity of stainless steel, glass, and acrylic equipment while maintaining thorough cleanliness.
  4. Low Particle and Fiber Residue: According to IEST standards, MicroPolx® 1900 exhibits minimal particle shedding. Constructed from continuous filaments, it remains virtually lint-free during use, which is crucial for maintaining compliance and preventing contamination.
  5. Cost Considerations: While MicroPolx® 1900 is a premium product, its efficiency means fewer wipes are required for the same level of cleanliness, thereby aiding in cost-effectiveness and compliance. It allows companies to standardize one trusted brand for various needs, simplifying validation and documentation.

Applications of Berkshire MicroPolx 1900 in Healthcare and Pharmaceuticals

Berkshire MicroPolx 1900 is designed for various cleanroom tasks in healthcare and pharmaceuticals due to its unique properties:

Aseptic Processing Areas: MicroPolx® 1900 effectively cleans RABS (Restricted Access Barrier System), gloveboxes, workbenches, and equipment surfaces in aseptic filling lines. By removing particulates and sanitizing them with sterile isopropyl alcohol (IPA), it helps maintain aseptic conditions. Its low-lint quality ensures no fibers are left behind, making it suitable for critical cleaning tasks.

Cleanroom Maintenance and Turnaround Cleaning: These wipes are used with cleaning agents to clean ceilings, walls, and floors at the end of production runs or during routine maintenance. Their large size (12″ x 12″) and durability enable efficient cleaning. After mopping, operators can hand-wipe critical touchpoints to ensure the environment is free from contaminants.

Equipment Cleaning in Pharmaceutical Production: MicroPolx® 1900 is effective for cleaning tablet presses, capsule-filling machines, and bioreactors. Its ability to pick up acceptable Active Pharmaceutical Ingredient (API) powders prevents cross-contamination. The wipes lift dust without smearing and trap particles, minimizing aerosolization and ensuring a safe cleaning experience.

Laboratory and Medical Device Manufacturing: In medical device cleanrooms and compounding pharmacies, technicians use MicroPolx® 1900 to clean devices during assembly and wipe down compounding isolators, ensuring cleanliness and reducing the risk of contamination. Its chemical compatibility prevents residue that could affect patient doses.

Support Areas (Gowning Rooms, etc.): Outside the core cleanroom, MicroPolx® 1900 is useful in controlled spaces like air locks and gowning rooms. It keeps these areas clean, further protecting the main cleanroom from contamination.

Overall, MicroPolx® 1900 enhances contamination control and operational efficiency in the healthcare and pharmaceutical industries, resulting in safer products and improved compliance with cleanroom standards. Validated wipes streamlines audit processes, as they are viewed favorably by inspectors and the FDA.