Agitators
Continuing development
Looking at a product synonymous with innovation and quality in bioprocess equipment.
During the last 20 years there have been a number of developments in innovative bioprocess equipment with the trademark Steridose. It started with the magnetically driven, bottom-mounted mixer (Sterimixer), followed by the ‘zero dead-leg’ aseptic diaphragm valve (Sterivalve). Later, a flush mounted flange (Steriflange) was introduced to replace standard tri-clamp ferrules welded on tanks. Other components were also developed through the years to satisfy specific needs of the market. These products have been tested in many applications around the world, from IV solutions to cell growth. The installed Sterimixer product alone is close to 4000 units. Steridose will continue to develop these products, as well as provide the highest quality of customer service support through its sales representatives and distributor network. The headquarters are located near Stockholm, Sweden, and include manufacturing facilities, main offices and R&D.Another manufacturing facility is located around 2400 miles north of Stockholm. To cover the US market, a sales office and a warehouse have been established in Wisconsin. The company has introduced a new concept in the manufacturing of aseptic components. Some of the challenges manufacturers face relate to the quality and traceability of raw materials and the reliability of supply of sub-components. In most cases, the companies designing and marketing the aseptic components are not the actual manufacturers. This can create major complications with regards to quality control and traceability as components may come from sub-suppliers that manufacture components for use in sectors other than pharmaceutical/biotech. This can cause the seller to loose the traceability of the parts included in the supplied component. For instance, if material certificates are not requested prior to placing an order, it may be impossible to get them after the order. Steridose has dealt with the issues of traceability and quality control by taking care of the complete process of developing, designing, manufacturing, marketing and selling the products it promotes, all under the umbrella of one group of companies.
Having design and manufacturing done at the same facility also greatly improves communication with customers. In particular, it helps to better understand particular needs on custom designed products. Steridose customers are speaking directly with the engineers that design and create the manufacturing drawings for the products. Another advantage found by having all processes done by one single group of companies is a significant reduction in cost, which makes Steridose products very competitive in the market. The quality of final pharmaceutical and biotech products is very closely related to the quality of components used to produce them. Steridose model of having control over all aspects of development, design, production, service and sales of Steridose components is a step forward in assuring the highest quality of the process equipment used in the manufacturing of pharmaceutical products.
The full range of Steridose components are specific to pharmaceutical and biotech applications, whichitself guarantees the highest level of traceability and quality control. Due to this, all materials that come to Steridose manufacturing facilities are carefully traced, and all single components manufactured are provided with a material certificate. This procedure is done for all Steridose parts, even if the customer does not request a certificate with the order. Furthermore, Steridose keeps a database with all certificates, which means that the certificates can be reproduced should the customer misplace them. This is done simply by providing the ID number marked on each part. There isn’t a price adder to provide such required additional certificates; they are simply parts of the product. Since Steridose is an ISO 9001 certified manufacturer, the company can assure that the proper documents are gathered and provided with all supplied products. Bottom line, this simplifies the validation procedure to endusers, creating cost savings and ensures that the products fully comply with FDA regulations. Quality is much easier to control and monitor by having R&D and manufacturing in-house. This also applies to the delivery times as the factors out of control of the supplier can be minimized.
Some of the challenges manufacturers face relate to the quality and traceability of raw materials and the reliability of supply of sub-components
