It was almost 10 hours for a line changeover to around 3 weeks of downtime for preparing a Stainless steel bioreactor for the upstream process. This stainless steel system required huge maintenance, cleaning and sterilisation after a batch of drugs were produced. This process always was costlier, time consuming and gave a sense of addition fear of cross contamination to the manufacturers.
To overcome the challenges of cross contamination and provide an aseptic environment at each stage of production with Increased Productivity the innovation of single use bags and components adoption came into huge demand.
Current GMP requires all kinds of safety and quality standards. Ami Polymer manufactures all the Single use components, bags, tubes and hoses in ISO Clean room class 7, with all the products gamma irradiated prior to their usage. It is ensured that the products meets the most important factors like the extractable and leachable (Bpog) and the biocompatibility USP 87, 88 and ISO 10993.
1) Increase the Productivity:- It eliminates the downtime of cleaning and validation between two stages of production.
2) Minimises the risk of Cross Containmination:- the traditional method had the risk of cross containmination between batches and products. Current method simplifies the process by disposing off the assemblies or bags after a batch.
3) Cost and Time:- The complexity involved CIP & SIP process, required more in the traditional stainless steel vessels, it got remarkably decreased with the new single use process. It thereby reduced cost of labour and material. The downtime also reduced and changeover is now reduced to 2-3 hours.
4) Scalable:- The single use products can be scalable cale from prototype to production, available with different sizes and volumes and easy to handle, with less labour or resources.
By Continuesouly monitoring the customer needs we manufacture the right and hygiene components for the pharma and biopharma applications? Ami Polymer adheres to provide solutions globally, we have built a team of expertise working on innovative new designs in the single use assemble products 24x7.
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Aswathy Nair is a highly accomplished international sales professional with a proven track record and expanding global market presence. She travels parts of South East Asian Countries like Singapore, Malaysia, Thailand, South Korea, Vietnam, etc. to meet our pharma/biopharma customers and provide them best fluid transfer solutions, offering wide variety of single use consumables to the industry. There are more than hundreds of customers delighted and enjoying our services in these regions.
