Why ALPS?

ALPS Hybrid 700 Series BFS/FFS Machine Salient Features:

• Smallest footprint for maximum output
• The Right Fit © – One machine can produce multiple products ranging from 0.1mL – 2000mL
• ALPS Designed Interchangeable Electronic Fill System for quick changeovers
• Patented Technology for “No Smashing” of vials/bottles during Deflashing process
• Energy efficient (30-35% more than others)
• Reduced (10-15%) plastic consumption
• State of the art Data Management System with Wonderware® by Aveva
• ALPS designed Unitary Base machines (Solid 304 Stainless Steel)
• Superior integration of pharmaceutical requirements such as, in-line Isolation Insertion Technology (IIT) that accommodates precise dispensing of eye drops via Tip & Cap assembly inserted in the bottle. Medical Devices that contain drug additives such as powdered capsules, can be mixed at point of use.

All ALPS Machines are designed and manufactured in Arlington Heights, Illinois, USA facility. Each ALPS machine is assembled in-house, tested and pre-validated prior to the Factory Acceptance Test (FAT). ALPS provides Installation, commissioning, after sales service and spare parts.

ALPS’ tailored solutions allow application of BFS/FFS technology in aseptic and non-aseptic product categories, while maintaining flexibility in container design.

ALPS also offers R&D services for Vial/Bottle Design including prototype mold development and product filling: sizes range from 100 microliters (0.1mL) to 2 Liters (2000mL).

We take pride in customer satisfaction and customer support. We want our customers to be successful while using ALPS machines and products.

ALPS 600 & 300 Series

Please contact us for information and availability of these series machines.

Isolation Insertion Technology (IIT)

This technology is used to enhance functionality of an already Robust Aseptic BFS/FFS technology to process. A few examples:

• A device or a sterile insert such as a tip & cap of for eye-dropper bottle can be fed through an isolator then placed in the bottle after the filling operation during the BFS process, prior to closing of the container, and hermitically seal the Insert into the vial/bottle. The Tip & Cap Inserts are made with precise dispensing orifice(s) to dispense a controlled drop of liquid product.
• Sterile drug additive(s) can be injected into the vial/bottle through a rubber stopper at the point of use.
• Sterile Powdered Capsules can be inserted into the containers and mixed at point of use with the liquid already present in the container (prior to opening the container for different therapies).

ALPS Designed Isolators

C-RABS(Closed Restricted Access Barriers) can have RTP (Rapid Transport Ports) or Transfer Chambers to load Inserts (e.g. eye drop inserts , rubber stoppers etc.) into the main isolator that has been integrated in-line with an ALPS BFS/FFS machine. These isolators maintain class 100 (ISO 5) for the Aseptic process. They include:

• VHP (Vapor Hydroxide Peroxide) Decontamination Cycle development for Sterility assurance of the Integrated process for Insertion (e.g. Tip & Caps) and the BFS/FFS process.
• Pre-validation Documents DQ/IQ/PQ for the IIT process
• Integrated LIVE Viable and Non-viable particle counters
• Glove Port Integrity tester
• Built-in Hydrogen Peroxide (H₂O₂)

Additional ALPS Options

This technology is used to enhance functionality of an already Robust Aseptic BFS/FFS technology to process. A few examples:

• Parison Shroud – This is a HEPA Filtration system integrated to the Parison Extrusion Zone which includes the encapsulation of Parison Head that extracts particulates from the area surrounding the Parison Cutting Zone during the BFS / FFS process.

• “Ultra Cut” Knife – This technology is used to cut the hot parisons (molten plastic tubes) at room temperature. An “Ultra Cut” Knife significantly reduces the production of non-viable particle (smoke) counts that are typically generated by using a hot knife to cut the extruded parison.