Pioneering Excellence: Sunkey’s Commitment to GMP Cleanroom Standards

In the intricate and critical landscape of pharmaceutical and food industries, Sunkey stands as a beacon of excellence, unwaveringly committed to achieving and surpassing the Class 100,000 GMP cleanroom standard. This standard, a hallmark of the Good Manufacturing Practice (GMP), is not just a regulatory requirement but a testament to Sunkey’s dedication to unparalleled quality and safety. GMP mandates stringent quality control measures encompassing raw materials, personnel, and facilities, and the scrutiny by the Drug Administration ensures that Sunkey’s production workshops meet the exacting criteria for Class 100,000 pharmaceutical production.

Elevating Standards for Health and Purity in GMP Cleanrooms

Sunkey’s workshops, meticulously aligning with the 100,000-level GMP cleanroom standard, play a pivotal role in mitigating air pollution and preventing cross-contamination. Beyond meeting regulatory requirements, this commitment significantly contributes to elevated product quality and increased production efficiency. GMP plants are categorized into different levels, with the 100,000 level, designed specifically for filling and inner packaging, imposing stricter cleanliness and health standards compared to the 300,000 level. Sunkey takes immense pride in featuring three 100,000-level GMP cleanrooms, collectively spanning over an impressive 20,000m2.

Adhering to GMP Standard Parameters

The heart of Sunkey’s commitment lies in strict adherence to GMP standard parameters, ensuring the highest quality in every aspect of production:

• Temperature: Maintained between 18~28℃ for both 100,000 and 300,000 grades, regulated at 1 time/shift according to JGJ71-90.
• Humidity: Kept at 45~65%, as per JGJ71-90, adjusted 1 time/shift for both Class 100,000 and Class 300,000.
• Air Change Times: For the 100,000 class, a minimum of 15 times/hour, and for the 300,000 class, at least 12 times/hour, with a static pressure difference ≥ 5PA.

GMP Cleanroom Specifics

Delving into the specifics of GMP cleanrooms, particularly the Class 100,000, reveals a commitment to precision and excellence:

• Microdust Criteria: Defined by the number of micro dust particles per unit volume, with thresholds set at ≤ 3500000 particles/m3 for ≥ 0.5 microns and ≤ 20000 particles/m3 for ≥ 5 microns.
• Microbiological Limits: Dictated by the allowable number of planktonic bacteria (not exceeding 500/cubic meter) and settling bacteria (not surpassing 10 per petri dish).
• Differential Pressure Perspective: Crucial maintenance of pressure differences, with neighboring purification workshops ≥ 5Pa, and 100,000 purification workshops and non-purification workshops ≥ 10Pa.
  

  

The Crucial Role of the GMP Cleanroom Standard

The Class 100,000 GMP cleanroom standard, especially in Sunkey’s production workshops, stands as a cornerstone in modern production facilities. Its construction demands not only strict adherence to norms and processes but also the establishment of a robust maintenance system. These measures are indispensable for ensuring the sustained purification of the production workshop and the maintenance of a pristine working environment. Sunkey recognizes that adhering to the GMP cleanroom standard is not just a compliance issue but a strategic imperative that aligns with the overarching goal of delivering high-quality and safe products to consumers.

Innovation and Evolution in GMP Cleanroom Excellence

Sunkey’s journey towards and beyond the Class 100,000 GMP cleanroom standard is not just a milestone; it’s a narrative of innovation and evolution. The commitment to maintaining three 100,000-level GMP cleanrooms showcases Sunkey’s proactive approach to quality, setting a gold standard in the industry. As the industry evolves, these standards will continue to shape and redefine, demanding constant innovation and dedication. Sunkey’s dedication to GMP cleanroom excellence ensures that its products consistently meet the highest standards of health and purity, reinforcing its position as a pioneering leader in the industry.

Conclusion: Sunkey’s Leadership in GMP Cleanroom Excellence

In conclusion, Sunkey’s unwavering commitment to GMP cleanroom standards sets it apart as a leader in pharmaceutical and food production. The three 100,000-level GMP cleanrooms serve as a testament to Sunkey’s dedication to providing consumers with products that meet the highest standards of health and purity. Beyond compliance, Sunkey views GMP cleanroom standards as a foundation for excellence, constantly innovating and evolving to stay at the forefront of industry expectations. As Sunkey continues its journey, the commitment to GMP cleanroom excellence remains a guiding principle, ensuring the continued delivery of products that exemplify the pinnacle of quality and safety.