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Use Of Disposable Components In Product Downstream Processing And Final Fill Operations Is Increasing

August 19, 2010

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Product Sheet: Prevas: Single Use Dosing Systems

The use of disposable components in product downstream processing and final fill operations is increasing as the technology for performing these steps in a single-use mode also increases. There is a high demand for systems that support single-use purification, formulation and filling operations.

In the past, filling line equipment was commonly dedicated entirely to a single product. However, this approach is no longer economically feasible except for the highest-volume drugs that support nearly continuous filling operations. Most filling lines today support multi-product operations. Traditional multi-product operations require validation of the level of product carryover after cleaning operations to ensure subsequent products are not contaminated. Certain product-contact parts are hard to clean to acceptable levels, and are therefore dedicated to specific products.

An alternative to filling equipment dedication is the use of single-use parts and assemblies. These systems can include components like bulk product bags, capsule filters, silicone tubing, and other plastic fittings and parts. Many of these parts can already be purchased pre-cleaned and pre-sterilized, and double or triple bagged for easy use within cleanrooms.

The Prevas family of aseptic disposable dosing systems by Bosch represents a new chapter in dosing system technology. Prevas is the first completely pre-assembled, pre-sterilized and pre-validated dosing system available for the clinical and production pharmaceutical and biotech filling market. This allows risk free scale up of filling operations in a single use format.

Prevas removes several risk factors from your filling operation. There is no more need for complicated cleaning procedures and validation protocols. The entire system is quickly installed and operational in a fraction of the time that previous systems required. The product is completely contained in the system reducing operator exposure to products.

  • Reduced risk, A new system for each batch means there is no risk of cross contamination and no risk of improperly cleaned parts.
  • Reduced Validation, pre-validated parts reduce the validation burden on your staff. Reduced costs, The cost of a dosing system is less than the cost of the labor time and materials involved in cleaning a traditional system.
  • Increased productivity, with quicker changeover time between batches your facility remains productive for more hours of the day.
  • Reduced resource consumption, no need for cleaning means no autoclave, steam, labor used in cleaning procedures.
  • Improved operator safety, greatly reduced exposure of product to operators.

Click Here To Download:
Product Sheet: Prevas: Single Use Dosing Systems

SOURCE:Bosch Packaging Technology

Bosch Packaging Technology

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