Ulinzi Latex appoints Schrack & Partner as main project consultant22 Apr 2016
Ulinzi Latex, the recently-launched male latex condom manufacturer, has appointed Schrack & Partner as a lead project consultant. As part of the agreement, the German consulting company will prepare Ulinzi Latex for medical device certification and co-formulate the underlying production concept, in order to achieve Ulinzi Latex’s vision of becoming the world’s largest condom manufacturer by volume.
Ulinzi Latex products will be manufactured in its own state-of-the-art production facility, HSNDS Latex, in Pakistan. The USD160 million project will be built on a greenfield site near Lahore, with production being gradually expanded in stages until full capacity is achieved in 2022. A pilot plant for product and process development is also planned.
Schrack and Partner will co-design the underlying production concept of the new facility, working in tandem with Ulinzi Latex. World-class processes will be developed, and lean manufacturing techniques will be customised to meet the rigorous requirements of medical device production. The associated manufacturing infrastructure including building layout and environmental conditions will also be defined, permitting even the production of Class III condoms.
From a regulatory standpoint, the consultants will build a robust quality management system, introduce state-of-the-art process development and validation and ensure that all technical regulations pertaining to condom production are fulfilled.
The consultation project will enable Ulinzi Latex to meet the highest international standards and regulations for medical devices, and to be certified for all key international markets. Its ultimate aim is to shape a manufacturing operation that goes above and beyond what is considered standard, and so to offer products of the highest quality that guarantee performance and safety.
Mr. Karl-Heinz Rathsam, Head of Business Development & Sales at Ulinzi Latex, said: “We are planning to become a global giant in the field of condom production, and plan a manufacturing capacity of more than 8 billion a year by 2022. To achieve this mission, we must operate in new ways and at new heights of excellence.
“Schrack & Partner will complement our business plans perfectly, as not only do they have an unrivalled expertise in medical device manufacturing, but they share our ethos of ‘thinking beyond the obvious’. They offer holistic thinking that goes way beyond regulatory requirements, and by working together I know that we can truly push the boundaries of condom manufacturing.”
About Schrack & Partner
Schrack & Partner was founded in Reutlingen, near Stuttgart in Germany in 1998. It is a consultancy company specializing in the field of medical device certification. Services include QM systems, technical documentation, training, process and product development support for registration purposes and internal auditing. Services are provided by four partners (Mr. Schrack, Mrs. Dr. Heinrich, Mr. Kiesselbach and Mr. Dorsch) and 10 further employees. A wide knowledge based on long experience in the medical field and more than 300 satisfied customers stand for their outstanding performance as an internationally operating consultant company.
Further Information about Schrack & Partner: www.schrack-partner.eu