How to Ensure Magnetic Separators Meet Compliance Standards

Magnetic separators are critical in maintaining product safety and quality in various industries, including food and beverage and pet food processing. They’re designed to remove ferrous contaminants from raw materials, intermediate products, and finished goods, such as metal shavings, rust, metal dust, nails, and other magnetic debris, including work-hardened stainless steel. However, to effectively serve their purpose, separators must be designed to properly comply with regulatory standards that ensure the final product’s safety, quality, and integrity is protected and maintained. 

This blog discusses the importance of compliance in magnetic separation, the key standards manufacturers must adhere to, and how to ensure that magnetic separators meet these requirements.

Why Compliance Matters for Magnetic Separators

Magnetic separators are used across industries subject to strict regulations to ensure product safety. For example, the food industry is governed by laws set by the U.S. Food and Drug Administration (FDA), the European Food Safety Authority (EFSA), and other regulatory bodies, which dictate standards for contamination control. Similarly, pharmaceuticals must adhere to Good Manufacturing Practices (GMP) as outlined by the U.S. Food and Drug Administration and other national health organizations.

Non-compliance or failure to meet these standards can lead to a range of issues:

• Product Contamination: In food and pharmaceutical industries, failing to remove ferrous contaminants can lead to injuries or health risks to consumers, triggering product recalls.
• Regulatory Penalties: Non-compliance with established standards can result in legal penalties, including fines or shutdowns, and damage a company’s reputation.
• Quality Assurance Failures: Separators that don’t meet industry standards can negatively impact the quality control process, leading to defective or unsafe products reaching consumers.
• Brand Damage: Inadequate separation and magnet systems not meeting industry standards may fail to protect product integrity and lead to large scale product recalls and brand damage.

To avoid these risks, businesses must ensure their separators comply with industry-specific regulations and international standards. 

Key Compliance Standards for Magnetic Separators

Several regulatory standards and certifications apply to separators depending on the industry in which they are used. These may include magnetic separation devices.

Some of the most important standards include:

Food Safety Standards

Separators used in food processing must comply with various food safety regulations. The most notable standards include:

HACCP (Hazard Analysis and Critical Control Points)

HACCP is a preventive approach to food safety that focuses on identifying and controlling potential hazards. Separators play a key role in controlling physical contaminants, one of the major hazards HACCP addresses. They should be placed at critical control points to remove ferrous contaminants before the food reaches consumers.

FDA Regulations

The U.S. Food and Drug Administration (FDA) regulates food safety under the Food, Drug, and Cosmetic Act and the Food Safety Modernization Act (FSMA). FDA-compliant separators must be designed and constructed using materials that meet FDA standards for food contact, ensuring they don’t introduce any contaminants into the food supply.

EU Food Safety Regulations (EFSA)

The European Food Safety Authority (EFSA) oversees food safety in Europe, ensuring that products meet stringent safety standards. Separators must be constructed of non-toxic materials and designed in a way that minimizes the risk of contamination.

Pharmaceutical GMP Compliance

In the pharmaceutical industry, separators are critical for removing metallic contaminants that could compromise drug purity. They must meet the following standards:

Good Manufacturing Practices (GMP)

GMP guidelines ensure that products are consistently produced and controlled according to quality standards. Separators in pharmaceutical production must be designed and operated according to GMP principles, which include proper maintenance, validation, and regular testing to ensure their efficiency.

FDA 21 CFR Part 210 & 211

These regulations outline the requirements for the manufacture of drugs, including specifications for preventing contamination. Separators used in drug manufacturing must adhere to these standards, ensuring that any contaminants are effectively removed.

Material and Safety Standards

Magnetic separators must be made from materials that are safe for the intended application. Key material standards include:

FDA CFR 21 177.2600

This regulation governs the use of materials in food-contact applications. Separators used in food processing must be made of non-toxic, food-safe materials that do not leach harmful substances into the product.

RoHS (Restriction of Hazardous Substances)

Separators used in industries like electronics manufacturing need to comply with RoHS standards, which restrict the use of certain hazardous materials in the manufacturing process.

UL and CE Certifications

These safety certifications ensure separators meet the required safety standards for use in specific regions. UL (Underwriters Laboratories) certification is important for electrical safety in the U.S., while CE marking is required for products sold in the European Union.

How to Ensure Magnetic Separators Meet Compliance Standards

Ensuring that separators meet compliance standards requires a combination of proper design, installation, maintenance, and regular testing. Here are the key steps to ensure compliance:

Choose a Certified Manufacturer

Start by selecting a reputable manufacturer that is well-versed in compliance standards relevant to your industry. Look for companies that have certifications such as ISO 9001 or ISO 22000, and check that they adhere to industry-specific standards like HACCP, FDA or GMP. Certified manufacturers will design separators to meet all necessary safety and regulatory requirements. Avoid low cost imported magnet assemblies – often these do not meet the required standards.

Understand the Application and Requirements

Each industry has its own set of compliance standards, and the separator must be tailored to meet these specific needs. Work with your supplier to ensure the separator is suited for your facility’s operations. Consider:

• The type of contamination you need to remove (ferrous, non-ferrous, or stainless steel)
• The size and configuration of the system (suitable for the production line)
• Materials used in construction (food-grade, FDA-approved, etc.)

Conduct Regular Testing and Calibrations

To ensure your separators continue to meet compliance standards, it’s essential to regularly test and calibrate them. Perform routine checks to verify that the magnets are working as expected and are capable of removing contaminants efficiently. Look for third party endorsed reporting programs and ensure magnetic separation equipment includes adequate reporting on strength, and reporting covers all aspects related to current magnet standards.

• Test for magnetic strength: The strength of the magnet must be regularly tested to ensure it meets specifications for the intended application.
• Ensure magnet remains compliant: Check magnet against relevant magnet separator standards to ensure compliance is ongoing
• Check for physical wear and tear: Regular inspections are necessary to detect any damage or deterioration in the separator’s components, such as the magnetic field strength or the casing, which could compromise its effectiveness.

Invest in Regular Maintenance and Cleaning

Separators should be maintained and cleaned regularly to ensure they continue to function properly. This includes:

• Cleaning the magnetic surface: Ferrous contaminants can accumulate on the magnetic surface, reducing efficiency over time. Cleaning the separators regularly ensures they remain effective.
• Revalidation: Separators must be revalidated periodically to ensure they are meeting required strength and performance standards.
• Replacing worn parts: If any part of the separator becomes damaged, such as the magnet or protective casing, it should be urgently replaced to avoid compromising compliance, causing serious safety risks and injury to operators, and toxic rare earth materials from contaminating the product.

Ensure Documentation and Record Keeping

Compliance with industry standards often requires thorough documentation of processes, inspections, and maintenance. Keep detailed records of:

• Calibration tests
• Maintenance schedules
• Inspection reports
• Cleaning logs
• Supplier certifications

This documentation serves as proof that you are adhering to the necessary compliance standards and can be crucial in the event of a regulatory audit.

Ensure Your Magnetic Separators Are Always Compliant With Our Validation Services 

Regular testing, proper maintenance, and diligent record-keeping are essential to ensuring that separators continue to function effectively and comply with relevant regulations. At Magnattack®, we provide HACCP international certified magnet validation services to help you determine and ensure your separators are compliant. Along with this service an extensive 3^rd party endorsed report will be provided. Contact us today to schedule a validation test.