Are you confident that your cleaning process could pass a regulatory inspection?
The issue of manufactured medicines that don’t meet quality standards is a leading cause of failure towards treating patients.
So where are things going wrong?
A primary root cause can be poor quality of active pharmaceutical ingredients (APIs), especially those that are being imported, along with deficient formulation of the finished pharmaceutical products (how the medicine is formulated using inactive ingredients). Add to that, contamination risk during drug production. It is essential that all of the visually accessible product contact surfaces of pharmaceutical manufacturing equipment are free from residue before manufacturing can commence.
Despite procedures and processes substandard medicines are still being produced as a result of inferior cleaning validation programs and residual contamination during the manufacturing process.
STEQ America is committed to helping manufacturers maintain the highest levels of cleanliness to meet cGMP requirements and eliminate deficiencies that compromise medicine quality.
As the official U.S. supplier of IWT Pharma’s premium cleaning solutions, STEQ America provides cutting-edge washing systems engineered and manufactured in Europe. For over 20 years, IWT has specialized in designing environmentally friendly, energy-efficient cleaning solutions for the life sciences and pharmaceutical industries worldwide. Today, many of the world’s leading pharmaceutical and life sciences companies rely on these superior washing systems to uphold the highest standards of hygiene and compliance.
Addressing an industry need for a cost effective, mobile, high pressure washing solution, IWT developed the M-Line Mobile High Pressure Washer. Suitable for a extensive range of applications, including bins and process tanks, the M-Line is built using AISI316L stainless steel components and supplies water via a pump capable of generating up to 1,2000 PSI pressure at the cleaning nozzle. The system is designed to minimize the use of chemicals and water usage thus reducing the need for effluent treatment and detergent consumption. Created to comply with the most stringent requirements of the pharmaceutical industry, the M-Line is fully cGMP and FDA compliant.
The most sought-after application of the M-Line is the cleaning of internal surfaces of bins which are in direct contact with the products being manufactured.
A typical bin washing setup involves the washing machine with the hydrokinetic lance mounted on a special lid designed to prevent water splashes from the bin’s upper opening, whilst performing thorough neck cleaning. The ergonomic design of this lid means an operator’s work is minimized, therefore saving their time and reducing the potential for human error.
Clean in Place (CIP) of manufacturing and processing equipment requires a deep understanding of the engineering of a device to clean, an accurate and feasible study, preparation and the conduction of a cleaning procedure, and several tests to verify the effectiveness of the overall process. STEQ America takes pride in providing you with the information you need in order to reach your targets and be an industry leader. That’s why we strive to offer you the highest quality, safest, most innovate and most durable cleaning solutions to improve your cleaning validation process. When GMPs are not properly followed, cross-contamination can occur among products manufactured at the same facility, leading to finished pharmaceutical products with dangerous levels of other ingredients not intended to be there. How can you prevent this? Avoid cross-contamination and microbial threats of this type by ensuring your manufacturing and processing equipment is properly cleaned before the changeover of products, and utilize cleaning equipment such as the M-Line with proper water and air handling systems to prevent the movement of particles and media from one medicine in production to the next.
Don’t rely on a visual inspection or inadequate cleaning equipment to assess only the visually accessible product contact surfaces of your pharmaceutical manufacturing equipment. Because it is crucial to patient safety, medicine quality, standards and regulatory compliance, invest in an IWT cGMP washing system today.