Pharmaceutical Homogenization of Solids: ANVISA and NR-12 Compliance

Overview

The pharmaceutical homogenization of solids is a critical process that requires precision and strict compliance with regulatory standards such as ANVISA and NR-12. Agimix, with 15 years of experience in the industrial agitation and mixing solutions market, offers robust and safe equipment to meet the demands of the pharmaceutical industry, guaranteeing the quality and safety of final products.

Our solutions are designed for the efficient mixing of powders and granulates, essential in the manufacture of medicines, supplements and cosmetics. Equipment such as the Ribbon Blender Mixer and the Biconic Mixer are developed to ensure perfect homogeneity, essential for the correct dosage of the principles active ingredients and therapeutic efficacy.

To optimize the process and ensure operational safety, we integrate auxiliary systems such as the Solids Desgrumador, which breaks down clods and agglomerates, and dust removal cabins that protect operators while feeding the equipment. compliance with NR-12 is a pillar in the development of our equipment, ensuring a safe and productive work environment.

Investing in Agimix equipment means opting for cutting-edge technology and a partner who understands the complexities of pharmaceutical production. Our mixers are built with high quality materials, such as stainless steel, and designed to facilitate cleaning and validation, crucial aspects for the pharmaceutical industry.

Pharmaceutical Homogenization of Solids: ANVISA and NR-12 Compliance

Benefits and advantages

Superior Homogeneity

Our mixers, such as the Ribbon Blender Mixer and the Biconic Mixer, guarantee a uniform distribution of ingredients, essential for the effectiveness and safety of products pharmacists.

Regulatory Compliance

All equipment is designed and manufactured in strict accordance with ANVISA and NR-12 standards, ensuring process validation and operational safety.

Security and Protection

Auxiliary systems such as the Solids Desgrumador and dust removal cabins minimize exposure to dust, protecting operators and the work environment, in addition to ensuring the integrity of the product.

Application Versatility

Our line of mixers serves a wide range of applications, from mixing fine powders to granules, with customization options for different volumes and material characteristics.

Process Optimization

With high-performance equipment, such as the V/Y Mixer, we reduce cycle time and increase production efficiency, resulting in greater productivity and lower operating costs.

Technical specifications

These specifications are not fixed for every piece of equipment: they represent possibilities available on some of the listed models. Contact our sales team to confirm the information and the ideal configuration for your operation.

Volumetric Capacity 50 to 5,000 liters
Building Material AISI 304 or 316L stainless steel (Sanitary Grade)
Internal Finish Sanitary polishing, Ra < 0.8 µm
Security Systems Compliance with NR-12, interlocks, protection grids
Types of Mixers Ribbon Blender, Bicônico, V/Y
Integrated Options Degrinder, dust removal cabin, dosing systems
Power System Reception Hopper - Rasga Sacos, Download Big Bag, Rosca Conveyadora
Cleaning and Maintenance Easy access and hygiene design (CIP/WIP)

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Frequently asked questions

Direct answers to the most common questions about this equipment and its application.

How important is ANVISA compliance for pharmaceutical mixers?

ANVISA compliance is crucial to ensure that pharmaceutical mixers meet quality, safety and good manufacturing practice (GMP) standards. This ensures the integrity of the product and the health of the consumer, avoiding contamination and guaranteeing the effectiveness of the medicines.

How does Agimix guarantee operational safety with NR-12 in its equipment?

Agimix guarantees operational safety through the incorporation of safety devices, such as interlocks, guardrails and emergency stop systems, in compliance with NR-12. This protects operators and minimizes the risk of accidents when handling equipment.

What types of mixers are best suited for pharmaceutical powders and granules?

For pharmaceutical powders and granules, the most suitable mixers are the Ribbon Blender, the Biconic Mixer and the V/Y Mixer. Each offers a specific mixing mechanism to ensure ideal homogeneity depending on the characteristics of the material and production volume.

What is a solids descaler and why is it important in the pharmaceutical line?

A solids degrummer is equipment that breaks down agglomerates and lumps formed in powders and granules, such as the Solids Desgrumador from Agimix. It is important in the pharmaceutical line to guarantee the uniformity of the raw material before mixing, optimizing the process and the quality of the final product.

How does Agimix equipment contribute to process validation in the pharmaceutical industry?

Agimix equipment contributes to process validation through a design that facilitates cleaning (CIP/WIP), sanitary grade construction materials (316L stainless steel) and complete technical documentation. This allows pharmaceutical companies to prove the reproducibility and consistency of their mixing processes.

Is it possible to integrate feeding and discharging systems into Agimix mixers?

Yes, it is entirely possible to integrate feeding and discharging systems into Agimix mixers to optimize the workflow. We offer solutions such as Reception Hoppers - Rasga Sacos, Big Bag Lowers and Screw Conveyors for efficient handling of raw materials and finished products.

What are the benefits of using 316L stainless steel in pharmaceutical mixers?

The use of 316L stainless steel in pharmaceutical mixers offers benefits such as high resistance to corrosion, ease of cleaning and sterilization, and low reactivity with products. This is essential to maintain the purity and quality of pharmaceutical ingredients, avoiding contamination and degradation.

Does Agimix offer customized solutions for specific needs of the pharmaceutical industry?

Yes, Agimix offers customized solutions to meet the specific needs of the pharmaceutical industry. Our engineers work closely with customers to design and manufacture equipment that suits unique volume requirements, material type, space and production processes.

Pharmaceutical Homogenization of Solids: ANVISA and NR-12 Compliance

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