Introducing the SP i-Dositecno LI Versa-Line™ Pharmaceutical Filling equipment, your ideal solution for robust and dependable fill-finish equipment that minimizes disruptions to your current setup. With its innovative design, this equipment offers easy accessibility from one side, allowing you to conveniently install it against a wall. This linear filling and capping system seamlessly integrates into any space, ensuring a streamlined operation.

Here are some key features of the SP i-Dositecno LI Versa-Line™ Pharmaceutical Filling equipment:
• Versatility: Whether you need to fill liquids or powders into vials, syringes, or cartridges, this equipment is capable of handling a wide range of substances.
• Cleanroom Ready: Engineered using premium stainless steel, this equipment meets the highest standards of cleanliness. It is fully compliant with cleanroom requirements, ensuring a sterile environment for your pharmaceutical operations.
• Full Compliance: The integrated software of the SP i-Dositecno LI Versa-Line™ is 21 CFR Part 11 compliant, adhering to the regulatory guidelines for electronic records and signatures. Additionally, you can opt for IQ/OQ validation packages to further ensure compliance and regulatory adherence.
Choose the SP i-Dositecno LI Versa-Line™ Pharmaceutical Filling equipment for a reliable, versatile, and compliant solution that seamlessly integrates into your existing infrastructure while maintaining a high level of cleanliness and operational efficiency.

Looking for a customizable fill-finish solution that ensures consistent batches? Look no further than the SP i-Dositecno BI or MI Micro-Line. Designed with a compact footprint, it offers the flexibility to fill both liquid and powder substances into bulk or ready-to-use (RTU) vials. With filling options of 50 or 200 units per minute (upm), it caters to your specific production requirements.

Here are some key features:
• Cleanroom ready: The system is designed to meet cleanroom standards, ensuring a controlled and sterile environment for your filling processes.
• Regulatory compliance: The equipment fully adheres to manufacturing regulations, including 21 CFR Part 11. It also provides integrated software and IQ/OQ validation packages for streamlined compliance.
• Versatility: The system accommodates a wide range of filling volumes, from 100µL to 500 mL, allowing you to handle various product sizes and formulations.
Experience the adaptability and reliability of the SP i-Dositecno BI or MI Micro-Line, tailored to suit your specific needs in fill-finish operations.

Application Examples:
• Human Injectables Products
• Ophthalmic Eye Care Solutions
• Veterinary Health Products
• Diagnostic & Test Kits
• Oral Solutions
• Powder Fill

Introducing our reliable fill-finish solutions, meticulously crafted to ensure the safe and swift delivery of your product to the market. The SP i-Dositecno SY Flex-Line™ is designed to optimize your production fill-finish process, regardless of space limitations, budget constraints, or regulatory demands. Rest assured, it maintains exceptional quality synonymous with the SP brand.

Key Features:
• High-speed production capability: Fill up to 21,000 units per hour (uph)
• Cleanroom compatibility: Suitable for operation in cleanroom environments
• Full compliance: Our solution meets the stringent requirements of 21 CFR Part 11. Additionally, we offer integrated software and IQ/OQ validation packages for your convenience.
With our trusted fill-finish solutions, you can confidently streamline your production and bring your product to market efficiently, without compromising on quality.

Application Examples
• Human Injectables Products
• Diagnostic & Test Kits
• Powder Fill
• Multi- or Mono-Dose Nasal Spray

Introducing the SP i-Dositecno RF Flex-Line™, a result of extensive expertise in fill-finish processes. This cutting-edge solution serves as your ideal production partner, streamlining your fill-finish workflow and accelerating your time to market. With the integration of innovative Stäubli robotics, it ensures precise and consistent transportation and filling of syringes, cartridges, micro vials, and vials within sterile and clean environments. Moreover, it adheres to the most rigorous regulatory standards.

Key Features:
• Achieve a high throughput of up to 4,000 units per hour (uph).
• Designed for seamless integration into cleanroom environments.
• Fully compliant with regulatory requirements, including 21 CFR Part 11. We offer integrated software and IQ/OQ validation packages to ensure compliance.

Application Examples
• Human Injectables Products
• Diagnostic & Test Kits
• Powder Fill
• Nasal Spray

Introducing SP i-Dositecno's SY Syringe Filling equipment: the ultimate solution for filling, stoppering, and plunger insertion. Our innovative robotics simplify manufacturing operations while ensuring sterility, accuracy, and compliance with regulatory requirements. With our systems, you can assemble syringes or cartridges swiftly in sterile, clean, and ready-to-fill (SCF) tubs, providing the utmost production protection. Here are the key features:
• Unmatched precision: Stäubli Robot precisely de-nests and re-nests syringes or cartridges.
• Cleanroom ready: Our equipment is designed for cleanroom environments.
• Full compliance: Our software adheres to 21 CFR Part 11 regulations, and IQ/OQ validation is fully supported.

Application Examples:
• Human Injectables Products
• Diagnostic & Test Kits
• Powder Fill

Streamline your ophthalmic manufacturing process effortlessly with the SP i-Dositecno Ophtha-Line™ filling solution. Experience unparalleled precision and sterility, ensuring top-notch quality for your eye-drop or eye solution products that employ three-piece container closures.

Key Features:
• Cutting-edge mechanical unscrambler that efficiently handles plastic containers of up to 500 mL
• Complete compliance: Integrated software adheres to 21 CFR Part 11 standards, and IQ/OQ validation packages are readily available.

Application Examples:
• Eye Drops
• Ophthalmic Eye Care Solutions

If you're seeking an exceptionally versatile solution for the production and filling of nasal sprays, search no more! The SP i-Dositecno BI and MI Nasal Spray Filling Machines provide a streamlined manufacturing workflow, ensuring precise and consistent rotary filling, stoppering, and capping. These machines boast a user-friendly design with servo-driven motion control, allowing them to fill at speeds of up to 50 or 200 units per minute (upm).

Key features of these machines include:
• Cleanroom readiness
• Full compliance: The integrated software is 21 CFR Part 11 compliant, and IQ/OQ validation packages are also available.
• Versatility: They can accommodate filling volumes ranging from 100µL to 500 mL.

If you're in need of a filling and stoppering solution for your small-scale operations and time is of the essence, search no more! Introducing the SP Hull LyoStar® BI I/L Filler—a sturdy and cost-effective R&D filling machine designed to fit seamlessly into your lab space, minimizing any disruptions.

Key Features:
• Efficiency and Consistency: Experience filling and stoppering that replicates the production environment, ensuring efficient and consistent results.
• Swift and Simple Setup: Changeover is a breeze, allowing for quick and easy configuration. Additionally, the machine offers the flexibility to store recipes for various container formats, enhancing its versatility.
Choose the SP Hull LyoStar® BI I/L Filler for a reliable and efficient filling and stoppering solution that meets your small-scale operational needs while saving valuable time.

Application Examples:
• Formulation Development & Stability Studies
• Cycle Optimization & Scale-up
• Lyophilization of Product with Organic Solvents in Addition to Water
• Laboratory Research & Development and/or Small Production Freeze-Drying
• Diagnostic Kits
• 96-Well Plates
• Serum Bottles & Vials

Introducing the SP i-Dositecno LI-C Linear Capping Machine - your dependable, secure, and consistent solution for all your capping needs. Seamlessly integrating into your fill-finish workflow, our linear capping machine guarantees reliability while ensuring the utmost safety. It effortlessly aligns with advanced aseptic processing methods like restricted access barrier systems (RABs) or isolator enclosures, providing you with complete assurance of vial sterility.

Key Features:
• Space-efficient design - Optimize your workspace and make the most of valuable floor area.
• Versatility at its best - Whether for ophthalmic or oral applications, our machine accommodates a wide range of uses.
• Regulatory compliance - Our systems meet the requirements of 21 CFR Part 11, offering package and audit trail capabilities for seamless adherence to regulations.

Application Examples:
• Pharmaceutical Processing – Ophthalmic & Oral Pharmaceuticals

Having equipment that can swiftly and precisely assemble syringes and cartridges is vital for the smooth operation of your pharmaceutical manufacturing process. The SY pharmaceutical labeling machine by SP i-Dositecno employs advanced robotic technology to insert plungers and apply labels, guaranteeing the safety and sterility of your products.

Key Features:
• Versatile: Designed to handle syringes or cartridges stored in sterile, clean, ready-to-fill (SCF) tubs.
• Cleanroom ready: Suitable for use in cleanroom environments, ensuring the highest standards of hygiene.
• Full compliance: The machine is fully compliant with 21 CFR Part 11 software requirements, and offers IQ/OQ validation packages for comprehensive validation.

Application Examples:
• Human Injectables Products
• Syringe and Cartridges