AranBiotech quality management system emphasizes on quality by design (QbD) along with end product testing. All our processes are subjected to a robust risk management procedure, validated and continuously monitored after product realization to ensure that the products meet their predetermined specifications and applicable regulatory requirements.
AranBiotech Single Use Systems are produced by trained personnel in validated ISO Class 8 (grade C) facilities. Employee hygiene, gowning and continuous monitoring of clean room environment are an essential part of these processes.
Raw material batches undergo quality testing and are accompanied by Certificate of Analyses. All vendors undergo a comprehensive qualification procedure. Each lot of product has a batch manufacturing record that ensures complete traceability of raw materials, equipment, manufacturing process, in-process controls, personnel and quality control test data.
All of our products are packed in double poly-ethylene bags or as per the customers specifications, before leaving the production clean room. The packaging is developed to maintain the integrity of the products and minimize the risk of damage during transportation. Our packaging engineers have developed a unique packing system designed not only to protect the product but also to optimize container loads during shipping, which is a big benefit for long distance and overseas shipping.