SP i-Dositecno (RTU) Debagging Machine
Effortlessly Unpack! Swiftly eliminate the protective packaging of sterilized, pre-filled syringes, vials, and cartridges. The SP i-Dositecno Ready-to-Use Debagging Equipment is perfectly suited for utilization in highly sterile environments such as restricted access barrier systems (RABs) and isolation chambers.
• Designed to meet cleanroom standards - constructed with top-quality stainless steel.
• Complete compliance - integrated software adheres to 21 CFR Part 11 regulations, with available IQ/OQ validation packages.
• Seamless integration - ready-to-use and seamlessly fits into your current fill-finish line.
Application Examples:
• Human Injectables Products
• Diagnostic & Test Kits
• Powder Fill
• UniDose or BiDose Nasal Spray
SP i-Dositecno (RTU) Denesting Equipment
Regarding your fill-finish workflow, the crucial elements are sterility and efficiency. You can confidently densest and renest with ease! Our denesting equipment, designed for ready-to-use (RTU) applications, is here to assist you in separating and reassembling your products effortlessly. You can have peace of mind knowing that the SP i-Dositecno Denesting Equipment is robust and efficient, ensuring the smooth transportation of your sterile, clean, ready-to-fill (SCF) components throughout your fill-finish workflow.
Features:
• Cleanroom ready: Crafted from high-quality steel, our denesting equipment is engineered to meet cleanroom requirements.
• Full compliance: Our equipment fully complies with 21 CFR Part 1 standards, and we offer integrated software and IQ/OQ validation packages for your convenience.
Application Examples:
• Human Injectables Products
• Diagnostic & Test Kits
• Intraocular Injectible Products
• Syringes, Cartridges, Vials
SP i-Dositecno Equipment for Delidding
Eliminate protective packaging while maintaining sterility with the SP i-Dositecno Manual or Semi-Automatic Equipment for Delidding. This advanced system utilizes heat and a vacuum gun to safely remove lids and liners from pre-sterilized containers, ensuring the minimal generation of particulates and optimal delidding efficiency. Our delidding equipment seamlessly integrates into your current systems, enhancing your fill-finish line.
Features:
• Designed to meet cleanroom standards, constructed with high-quality stainless steel materials.
• Complete compliance with regulatory standards, including 21 CFR Part 11. Integrated software and IQ/OQ validation packages are available to support validation processes.
Application Examples:
• Human Injectables Products
• Diagnostic & Test Kits
SP i-Dositecno (RTU) Rod Inserter
Ensure a secure position for your syringe plunger by utilizing the SP i-Dositecno Ready-to-Use (RTU) Rod Inserter. Designed specifically for applications in highly sterile environments like restricted access barrier systems (RABs) and isolation chambers, this tool allows you to fill syringes with utmost confidence.
Features:
• Compatible with the SP i-Dositecno RF Flex-Line™
• Crafted from top-grade stainless steel to meet cleanroom standards
• Complete compliance with 21 CFR Part 11, offering integrated software and optional IQ/OQ validation packages for your convenience.
Application Examples:
• Human Injectables Products
• Diagnostic & Test Kits
