Permanent Magnetic Separators Self Cleaning For Active Pharmaceutical Ingredient

Product Specification

Self-Cleaning Magnetic Separator for Active Pharmaceutical Ingredient (API) Powders

Product Overview

The Self-Cleaning Magnetic Separator for API powders is a precision iron removal device specifically designed for the production of Active Pharmaceutical Ingredients (APIs). Addressing the extremely high purity requirements of APIs, the equipment utilizes a high-gradient magnetic field design and precision manufacturing processes to efficiently remove micron-sized ferromagnetic impurities. This ensures APIs comply with the Chinese Pharmacopoeia and ICH Q3D guidelines for elemental impurities. The equipment is suitable for various API powders, meets GMP standards, and guarantees drug quality and medication safety.

Product Advantages

1. High-Precision Iron Removal: High-gradient magnetic field design adsorbs ferromagnetic impurities as small as 0.5μm. Iron removal rate ≥ 99.9%, meeting the high-purity requirements of APIs.

2. Clean Production: Compliant with international pharmaceutical quality management regulations such as GMP, FDA, and EU-GMP. Contact parts are made of 316L stainless steel with a surface roughness of Ra ≤ 0.4μm.

3. Intelligent Control: Integrated with a PLC control system supporting remote monitoring, data recording, and electronic signatures, meeting GMP data integrity requirements.

4. Customized Service: Equipment solutions can be customized based on customer material characteristics and production capacity needs, addressing iron removal challenges in specific scenarios.

Product Parameters

Case Benefits

Implementation of a self-cleaning iron removal system in an API company with an annual production capacity of 500 tons achieved the following benefits:

• Quality Improvement: API iron content was controlled below 0.3 ppm, complying with ICH Q3D guidelines. The product qualification rate increased by 25%.

• Certification Achieved: Successfully passed FDA on-site inspections and EU GMP certification, obtaining export qualifications.

• Cost Savings: Reduced manual cleaning operations, saving approximately 30,000 CNY annually in labor costs. Avoided rework losses of about 100,000 CNY due to iron contamination.

• Market Expansion: Stable product quality enabled entry into high-end European and American markets, increasing annual export revenue by 1 million USD.

Q&A

Q1: Can the equipment handle high-purity APIs?

A1: Yes. The equipment features a high-gradient magnetic field design and precision manufacturing, meeting the iron removal requirements for APIs with purity levels above 99.99%, ensuring compliance with international standards.

Q2: Does high-pressure flushing affect API quality?

A2: No. The high-pressure flushing uses Water for Injection (WFI) or Purified Water, followed by automatic drying to prevent moisture residue. The process occurs in a sealed chamber without contacting the material, ensuring API quality remains unaffected.

Q3: Does the equipment support remote monitoring?

A3: Yes. The equipment is equipped with a PLC control system and industrial Ethernet interface, supporting remote monitoring, data logging, and fault diagnosis. Real-time equipment status can be viewed via mobile app or computer, enabling intelligent management.