Ensuring regulatory compliance with hygienic, compliance-ready sieving solutions
India's pharmaceutical industry, rightly known as the "Pharmacy of the World," is at a pivotal moment. A strategic national push for self-reliance in Active Pharmaceutical Ingredients (APIs), backed by government initiatives, is set to strengthen India's global leadership. However, this ambition comes with a critical prerequisite: unwavering compliance with the world's most stringent regulatory standards. With bodies like the U.S. Food and Drug Administration (FDA) increasing their scrutiny and conducting unannounced inspections, being always inspection-compliant is no longer an option, it's a condition for survival.
The problem: The high cost of non-compliance
For an API manufacturer, a regulatory audit is a high-stakes event. A single observation related to contamination or inadequate cleaning validation can have severe consequences, including import alerts, product recalls, costly remediation, and significant damage to the company's reputation. One of the most critical areas of focus for inspectors is the prevention of cross-contamination between different product batches. This requires processing equipment that can be dismantled, cleaned, and inspected quickly, thoroughly, and repeatably. Any equipment with hard-to-clean areas or complex disassembly procedures represents a major compliance risk.
The solution: Designing for compliance-readiness
At Russell Finex, we design our pharmaceutical-grade separation equipment with compliance at its core. We understand the pressures of regulatory audits and provide solutions that help manufacturers pass inspections with confidence. Our equipment is engineered not just for performance, but for the realities of a GMP-compliant environment.
Our Russell Compact Airlock Sieve™ is a vibratory sieve specifically designed to address the challenges of API processing and regulatory compliance. Its key features include:
- Tool-free assembly and disassembly: Operators can dismantle and reassemble the entire machine in minutes without the need for any tools. This drastically reduces downtime for cleaning and inspection.
- Crevice-free, hygienic design: All product contact parts are polished to the highest standards and are free of crevices, eliminating potential bug traps where contamination could hide. This makes cleaning validation simpler and more reliable.
- Easy to clean: The simple design with minimal contact parts ensures that every surface can be easily accessed and thoroughly cleaned, providing the verifiable proof of cleanliness that auditors demand.
Proven performance in API manufacturing
Saneca Pharmaceuticals, a leading European contract manufacturer, needed to improve its API processing capabilities while meeting strict customer requirements for particle size distribution (PSD). They installed our Russell Compact Sieve®, which now allows them to effectively process 100 to 400 kg of APIs per shift. The machine not only met their PSD requirements but also enhanced their overall manufacturing capabilities within a compliant framework.
Fortify your operations
Don't let your processing equipment be a point of failure in your next regulatory audit. Invest in a solution that is designed for compliance and trusted by pharmaceutical manufacturers worldwide.
- Explore our full range of hygienic separation equipment for the pharmaceutical industry.
- Read the Saneca Pharmaceuticals case study to learn more about sieving APIs to precise specifications.
At Russell Finex, we provide solutions that are built for sustainable recycling. Our equipment is designed to support a closed-loop recycling system, helping manufacturers to reduce plastic waste, lower dependency on fresh plastics, protect downstream equipment from damage, and improve overall production efficiency.
Whether you are looking to reclaim post-industrial scrap or purify plastic wash water, we have a range of solutions. Contact us to explore how we can support your in-house recycling goals.
