Acerta® DS1 Dispensing System

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Performance Specifications
Ordering Information
Technical Library

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:

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

Performance Specifications (return to top)

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
Height, mm	Base: 334; Reservoir holder: Adjustable from 591 to 704
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	4–30
Relative Humidity	24 to 85%, non-condensing
Sanitization	Tested for compatibility with 70% IPA and Spor-Klenz® Sanitizer
Product Enclosure Rating	IP54
Utility Requirements	100–230 V/50–60 Hz

Specifications - Disposable Module (return to top)

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

Ordering Information (return to top)

Please select 5 or fewer Items to compare.

Hardware

Compare	Catalogue No.	Description	Qty/Pk
	AFH01SSA0	Acerta DS1 Dispensing System	1	» Add to Cart

Disposable Modules

Compare	Catalogue No.	Description	Qty/Pk
	AU01AABLAB	Acerta Disposable Module Code 200 L-type (1 m) Dispense Tube	1	» Add to Cart
	AU01ABELAB	Acerta Disposable Module Code 300 L-type (1 m) Dispense Tube	1	» Add to Cart
	AU01ACELAB	Acerta Disposable Module Code 400 L-type (1 m) Dispense Tube	1	» Add to Cart
	AU01ADJLAB	Acerta Disposable Module Code 500 L-type (1 m) Dispense Tube	1	» Add to Cart
	AU01AABMAB	Acerta Disposable Module Code 200 M-type (0.35 m) Dispense Tube	1	» Add to Cart
	AU01ABEMAB	Acerta Disposable Module Code 300 M-type (0.35 m) Dispense Tube	1	» Add to Cart
	AU01ACEMAB	Acerta Disposable Module Code 400 M-type (0.35 m) Dispense Tube	1	» Add to Cart
	AU01ADJMAB	Acerta Disposable Module Code 500 M-type (0.35 m) Dispense Tube	1	» Add to Cart