Dispoline India Private Limited

All our core values revolve around our commitment to integrity and ethics. This is essential in all our dealings.

We seek to have mutually beneficial relationships with all people we deal with. Customers, Principals, Vendors, Employees, as well as the society at large, with whom we intent to have a long term relationships that revolves around the basic principle of Win – Win.

We strive to use innovative practices to improve the value, quality as well as ensure effective solutions for our customers. We intend to do this by involving our Customers, Principals, employees and all vendors to ensure that new products/solutions that create value are delivered to our customers.

Change being a constant, we seek to keep our Customers, Employees as well as all concerned updated with all relevant information that is beneficial to them. We strive to do this through continuous education programmes, which are conducted by experts in their respective fields.

• The Sterilization process has been validated according to ISO 11135 standards and a protocol is established to ensure the process repeatedly delivers Sterility Assurance Level 10-6 (SAL) to the product. A set of 16 Biological indicators (1.5 BI's per Cu. Mtr) are sent with each batch of sterilization for routine monitoring of the sterilization process, and then incubated for 48 hours @37 degrees before the product is released. All packs have Internal and External chemical indicators for a visual check of exposure to ETO. The internal chemical indicators are peel off labels with batch & production details, printed on them, in order to transfer them to patient records for traceability.
• Pouch Packaging conforms to EN 868 and are sourced from a manufacturer who conforms to EN ISO 13485 & ISO 11607 - 1
• Packaging Sealing is done by state of the art machines with online printing and the sealing process is validated as per EN ISO 11607-2, and have an integrated system to evaluate critical parameters like Pressure, Temperature and Time and these are recorded. To ensure traceability protocols are met.
• The medical fabrics are sourced from the best manufacturers around the globe and conform to various standards as per product applications as well as specific customer requirements. Some of the standards applied are AAMI PB70, EN 13795, EN ISO 11607 etc.
• Our Medical Fabrics undergo Batch/Run Wise Monitoring of Critical Quality Parameters and are documented.
• The medical fabrics are also subjected to Cytotoxicity and Skin (Dermal Irritation) Tests.
• Residual tests for Ethylene Oxide, Ethylene Chlorohydrin & Ethylene Glycol as per ISO 10993-7
• Sterility Tests done as per ISO 11737-2
• Bioburden Analysis done as per ISO 11737-1
• Usage based sealing methods are followed

• All traceability protocols with regard to the product and raw materials are followed.