The pharmaceutical industry demands the highest levels of precision, safety, and regulatory compliance to ensure product quality and patient safety. Hosokawa Micron offers advanced containment and size reduction technologies specifically designed to meet these stringent requirements. Our solutions help pharmaceutical manufacturers maintain contamination-free processing, optimize particle size, and ensure consistent product quality. Backed by extensive industry expertise, we work closely with clients to tailor equipment and systems that comply with regulatory standards while enhancing operational efficiency. This combination of cutting-edge technology and deep knowledge empowers pharmaceutical companies to confidently navigate complex production challenges.
Hosokawa Micron provides precision-engineered solutions for essential pharmaceutical processing stages such as offloading, discharging, charging, formulation, dispensing, and sterility testing. Our expertise also covers specialised fields including cell and gene therapy isolators, radiopharmaceutical production, and environmental control systems. Collaborating closely with manufacturers, we ensure strict regulatory compliance, maintain product integrity, and optimize operational performance throughout the production process. Our tailored equipment and process solutions support pharmaceutical companies in delivering safe, high-quality products efficiently while meeting the evolving demands of this highly regulated industry.
Our expertise is focused on a wide range of applications within the pharmaceutical industry:
Offloading / Discharging
Charging
Formulation / Dispensing
Sterility Test
Cell & Gene Therapy Isolator
Radiopharma
Offloading and discharging operations are critical stages in pharmaceutical manufacturing, where both containment and cleanliness must be maintained to protect operators and preserve product integrity. Hosokawa Micron’s advanced Offloading Isolator is purpose-built for the safe, dust-free transfer of finished or intermediate materials into final packaging or bulk containers.
Designed for environments where GMP compliance, hygiene, and high-containment are essential, the isolator supports manual, semi-automatic, or fully automated workflows. With containment levels up to OEB 5 and higher, it ensures secure offloading of powders and granules while maintaining air purity through HEPA filtration. Ergonomically placed glove ports, integrated weighing options, and compatibility with split butterfly valves, continuous liners, or liner clamping systems all contribute to a streamlined, operator-safe process.
The offloading isolator is fully cleanroom compliant and can be fitted with CIP/SIP systems, supporting contamination control and efficient changeovers. It also integrates easily with de-lumping equipment and downstream packaging lines—making it a flexible solution for batch or continuous production environments.
Whether discharging active pharmaceutical ingredients or formulation blends, Hosokawa Micron’s Offloading Isolator delivers robust protection for people, products, and process integrity.
Efficient and contained charging of materials is a vital step in pharmaceutical production, particularly when handling potent compounds or sensitive formulations. At Hosokawa Micron, we offer highly engineered solutions that support safe, accurate, and GMP-compliant material transfer into reactors, mixers, mills, or downstream isolators.
Our Process Containment Isolators are designed to create a controlled environment where APIs or intermediates can be introduced into the process with maximum operator and product protection. These isolators provide ergonomic access, safe gloveport operation, and a cleanable stainless steel design, all while achieving containment levels of OEB 5 or higher.
For larger volume handling or flexible production requirements, our Filling & Weighing Systems offer scalable, contained solutions for accurately dosing powders into reactors, mixers, or isolators. Designed for precision and safety, these systems ensure GMP-compliant transfer and batch control, reducing the risk of cross-contamination and exposure.
Whether you’re working with hazardous powders or require aseptic charging environments, our solutions are developed to reduce risk, maintain cleanliness, and streamline your workflow. Each system can be fully customised to suit process requirements, from mobile isolators for flexibility to fully automated charging for high-volume production.
At Hosokawa Micron, we understand the pressures of pharmaceutical manufacturing and the importance of precise, repeatable charging operations. Our solutions are designed to ensure compliance, protect your operators, and safeguard your product at every step.
Accurate formulation and dispensing are at the heart of pharmaceutical manufacturing, ensuring product consistency, regulatory compliance, and patient safety. Hosokawa Micron offers advanced containment solutions that enable safe and precise weighing, blending, and subdividing of raw materials—particularly when working with potent APIs or multi-component formulations.
Our Formulation Dispensing Isolators provide a fully enclosed environment for weighing and dispensing operations. Designed for high containment performance of OEB 5 and higher,, these isolators ensure that powders and active ingredients are handled safely while maintaining process accuracy and efficiency. Integrated weighing systems, gloveports, and airflow management deliver ergonomic operation with minimum risk of cross-contamination or exposure.
These systems are ideal for batch processing environments where flexibility, cleanliness, and documentation are critical. Whether used for primary formulation steps or final dispensing into smaller containers, our isolators support cGMP standards, are easily cleanable, and can be configured with pre-chambers, Rapid Transfer Ports (RTPs), or nitrogen purging for handling sensitive or hygroscopic materials.
Every Hosokawa solution is tailored to your formulation requirements—whether you’re developing new drugs or scaling up commercial production. Our expert engineering ensures seamless integration into your facility, with a focus on operator protection, repeatable accuracy, and reduced validation time.
Hosokawa Micron’s formulation and dispensing technologies help pharmaceutical manufacturers maintain total control over complex processes—safely and consistently.
Sterility testing is a critical control point in pharmaceutical manufacturing, where the highest standards of aseptic integrity and contamination control must be met. Hosokawa Micron supports this vital function with isolator technologies designed to maintain a sterile, secure environment throughout testing procedures.
Our Sterile Isolators are engineered specifically for pharmaceutical quality control and microbiological testing environments. These systems provide a Grade A (ISO 5) environment under positive pressure, ensuring total isolation from external contaminants while allowing controlled manipulation of samples and equipment inside the chamber. They are ideally suited for sterility testing of injectable drugs, biologics, and other parenteral products.
With features such as Rapid Transfer Ports (RTPs), cleanroom-compatible materials, and HEPA-filtered unidirectional airflow, our isolators support compliance with GMP Annex 1 and FDA aseptic processing guidance. All contact surfaces are smooth, cleanable, and constructed from pharmaceutical-grade stainless steel to allow for straightforward decontamination via integrated hydrogen peroxide (VHP) bio-decontamination systems.
Operators can conduct sensitive tests safely and efficiently, with excellent visibility and ergonomics. The isolators can also be configured for use with automated or manual sterility testing devices, ensuring flexibility across lab workflows.#
With Hosokawa Micron’s sterility testing solutions, pharmaceutical manufacturers gain a reliable, compliant, and fully contained environment to protect product integrity and minimise the risk of false positives or environmental interference during critical testing stages.
Cell and gene therapies demand ultra-clean, flexible environments to protect both product and personnel during highly sensitive manufacturing processes. At Hosokawa Micron, we understand the unique challenges of handling live cells, viral vectors, and gene-modifying agents—where sterility, containment, and process control are paramount.
Our Cell & Gene Therapy Isolators are designed to support aseptic operations while maintaining strict containment boundaries, ensuring compliance with advanced therapy medicinal product (ATMP) regulations and GMP Annex 1. These isolators provide Grade A environments suitable for sterile compounding, media preparation, and closed-system processing. Positive or negative pressure regimes can be configured depending on biosafety or product protection requirements.
The isolators feature unidirectional airflow with HEPA filtration, gloveport access, integrated monitoring, and optional hydrogen peroxide (VHP) decontamination. They’re also compatible with single-use technologies, making them ideal for small-batch and personalised medicine production, where minimising cleaning validation and cross-contamination is essential.
Whether you’re scaling up clinical batches or working in pre-commercial development, Hosokawa Micron’s isolators provide a robust, flexible solution to manage the complexity of ATMP workflows. Our systems are engineered with modularity and cleanroom integration in mind, supporting seamless incorporation into cell culture, formulation, or fill-finish environments.
For innovators in regenerative medicine, our containment technologies offer a proven platform for safety, sterility, and success in next-generation pharmaceutical manufacturing.
Handling radioactive pharmaceutical compounds requires the highest standards of containment, shielding, and precision. At Hosokawa Micron, we provide advanced containment solutions that enable safe and compliant processing of radiopharmaceuticals—protecting operators from exposure while maintaining product integrity throughout critical manufacturing stages.
Our Process Containment Isolators are custom-engineered to meet the stringent requirements of radiopharma environments. These isolators combine high-level operator protection with integrated shielding and robust negative pressure control, making them ideal for processes involving short half-life isotopes, compounding, dispensing, or final product preparation.
Built to accommodate lead glass, shielded transfer systems, and radiological safety features, our isolators support operations within PET and SPECT facilities, nuclear medicine labs, and sterile manufacturing environments. Seamless integration with cleanroom infrastructure and radiation monitoring systems ensures compliance with GMP, radiological safety, and pharmacy-grade standards.
Whether you’re preparing small-batch diagnostic agents or therapeutic isotopes, our isolators enable controlled, contained, and traceable handling. Additional features like rapid decontamination, glove port ergonomics, and shielded waste management enhance workflow efficiency while minimising radiation exposure.
Hosokawa Micron’s radiopharma containment systems are tailored to your process needs, supporting sterile and non-sterile environments and ensuring your operators, products, and patients are protected from start to finish.
Speak to our team of experts today to see how we can help you on your journey to smarter material handling.