Acerta^® DS1 Dispensing System

Acerta® DS1 Dispensing System The Acerta DS1 Dispensing System is a single-head liquid filling system with a pre-assembled, sterile disposable filling module. The Acerta DS1 system consists of a stainless steel base unit, hand-held interface, and the disposable filling module. This single-head system is ideal for use as a manual filling system, and is designed to fit in a biological safety cabinet. The system can also be integrated into a new or existing filling line. The design of the Acerta DS1 system offers complete product containment, ensuring product sterility and safety of personnel and making the system especially suited for cytotoxic and biohazardous fills. The unique design minimizes product hold-up volume at the end of the fill process. After the filling campaign is complete, the disposable module is easily removed and discarded in preparation for the next filling campaign.

Applications
The Acerta DS1 dispensing system is intended for use with final sterile injectables and diagnostics across a full range of filling capacities in biotechnology and classical pharmaceutical manufacturing. Specific application areas for the Acerta DS1 dispensing system are:
- R&D Filling
- Clinical Trial Manufacturing
- Production Fill and Finish
- Cytotoxic Products
- Gene Therapy Products
- Contract Fill and Finish Manufacturers
- Products Requiring Non-Metal Contact


The Base Hardware Unit
The Acerta DS1 hardware consists of a 316L stainless steel base hardware unit and a small hand-held controller connected to the base. The switches and button on the base unit control the basic system functions – power on/off, function selection, manual dispense and emergency stop. Other interaction with the system is conducted via the hand-held controller. The base unit has the necessary fixtures for easy installation of the disposable module and for integration into new or existing filling lines.



The Disposable Module
All product contact surfaces are part of the disposable filling module. The module consists of a product reservoir, tubing, fittings, and a filling needle, and is designed for easy installation on the base unit. The module is preassembled, gamma sterilized and triple-bagged for added convenience. The gamma-sterilized filling module eliminates the need for autoclaving or steam sterilizing piston pumps, tubing, and filling needles. The sterile filling module is opened in the filling suite and easily assembled onto the stainless base unit in less than 10 minutes. Because the module is disposable, it eliminates cleaning and preparation for the next fill process.



Disposable Module Options

Code 200 Dispense Weight Range 0.2 – 1.1g   Code 300 Dispense Weight Range 0.6 – 2.5g   Code 400 Dispense Weight Range 0.9 – 4.5g   Code 500 Dispense Weight Range 2.0 – 10.0g

Performance Specifications

For use with aqueous liquids (excludes emulsions and suspensions) Fill Weight Range 0.2 – 10 g Fill Rate in Fill per Minute (fpm) 0.2 g ≤ fill weight ≤ 1 g 40 1 g < fill weight ≤ 3 g 30 3 g < fill weight ≤ 5 g 20 5 g < fill weight ≤ 10 g 10 Repeatability Over 4 Hours (includes one adjustment in the first 15 minutes from the start of the process) 0.2 g ≤ fill weight ≤ 1 g ≤ 0.005 g 1 g < fill weight ≤ 10 g ≤ 0.5% target wt Target Fill Volume Accuracy (deviation from target weight) 0.2 g ≤ fill weight ≤ 1 g ≤ 0.003 g 1 g < fill weight ≤ 10 g ≤ 0.3% target wt Maximum Number of Dispenses to Target (2 dispenses per weight measurement): 10 Tests based on water at 23 °C

Specifications - Base Hardware Unit    (return to top)

Physical Properties Weight, kg (lb) 13 (28) Length, mm 298.5 Width, mm 203.2 Height, mm Base - 333.8; Reservoir holder - Adjustable from 591 to 703.6 Enclosure Material Majority of exposed surface (non-product contact) is 316L stainless steel with external Ra of <45 µm Hand-held Controller Length x Width x Height, mm 209.6 x 113.8 x 28.6 Cord Length 2.13 m (7 ft) Language Options English, French, German, Italian and Spanish options included in each controller Operating Conditions Pinch Valve Life Qualified for 3 million cycles Temperature Range, °C 4 to 30 Relative Humidity 24 to 85%, non-condensing Sanitization Tested for compatibility with 70% IPA and Spor-Klenz® Sanitizer Product Enclosure Rating IP54 Utility Requirements 100//240 V 50//60 Hz

Specifications - Disposable Module

Physical Properties Width, mm 230 Height, mm 89 Approximate Operating Volume, mL 120 Materials of Construction Contact Materials Fittings - HDPE; Reservoir - ULDPE; Feed tubing - Pharmapure® Tubing; Supply, Return, Dispense Tubing and Sight tube - Platinum cured silicone; Dispense needle - Polycarbonate Non-contact Materials Feed connector dust cover - LDPE; Dust cover tie wrap - Nylon; Needle cap - Polyethylene; Sight tube clips - Valox® Resin; Reservoir - Polyester; Feed connector cap - PVC Functional/Mechanical Specifications Single Use Disposable module is not designed for re-use after a fill process Tubing in Pinch Valves No visible tubing cracks when tested at 60 fill/min ≥8 hours Minimum Shelf Life 1 year Integrity Testing 100% integrity tested Cleanliness TOC ≤10 ppm TOC after static soak for 60 minutes with LRW (lysate reagent water) Particles Meets USP 27-NF22 (788), EP (2004) (2.9.19) based on 10-mL vials Toxicity Non-toxic per the current USP (88) Safety Test Component Materials Component materials meet the criteria for the USP (88) Class VI Biological Test for Plastics USP Bacterial Endotoxins < 0.5 EU/mL as determined using the Limulus Amebocyte Lysate (LAL) test Chemical Compatibility Liquid properties compatible with aqueous solutions in a pH range of 2.5 to11 Others liquid solutions per material supplier’s recommendations Sterility Sterile by gamma radiation. Meets current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle

Module Options There are four supply/sight/dispense tube configurations to choose from. All tube and needle dimensions are internal diameter (ID). Weight Range (g) Sight Tube (in.) Supply Tube (in.) Dispense Tube (in.) Needle Tip (in.) Code 200 0.2 g – 1.1 0.125 0.0625 0.125 0.030 Code 300 0.6 g – 2.5 0.1875 0.125 0.125 0.060 Code 400 0.9 g – 4.5 0.25 0.125 0.125 0.060 Code 500 2.0 g – 10.0 0.375 0.1875 0.1875 0.090