Firma:              Zymark

Modell:            Prelude

Kommentar:   Dokumente engl.

The Zymark Prelude Workstation is a benchtop instrument designed to automate sample preparation and analytical injection for solid dosage forms, powders, feeds, capsules, and blend samples. Up to 100 samples can be staged for content uniformity, assays, blends, or any combination of up to ten different methods without human intervention. The Prelude Workstation can run from four to eight assays per hour. After solubilization, the Prelude Workstation can filter, dilute, store, or inject the sample into an HPLC or UV/Vis spectrophotometer. The workstation allows up to nine solvents for maximum flexibility. The calibration rack allows you to run system suitability or more complex standard patterns during your methods.

Using software designed especially for solid dosage form preparation, you can develop methods in minutes, and run them immediately. You can also easily insert, delete, or change steps, as well as adjust any of the process parameters.

Every step of the process is monitored by a precision electronic balance to provide a clear, defensible record of the liquid handling operations. The data is automatically documented and logged into a secure, read-only database. All raw data is also exported to an Excel file for easy accessibility with the Advanced Data Channels accessory. This information can also be made available to laboratory information systems, chromatography data packages, and individual spreadsheet applications, without compromising the integrity of the original record.

Operational Specifications

Sample Capacity:                    50 to 200 samples

                                               50 to 300 samples with extended rack capacity accessory

Containers                               16 mm x 100 mm tube (12 mL max working volume)

(Liquid Handling):                    13 mm x 100 mm tube (8 mL max working volume)

Containers                               4 mL Wisp Vials

(Dry Weighing):                       11 mm GC Vial

                                               8mm x 20 mm Alliance Vials

                                               16 mm x 100 mm tube

                                               13 mm x 100 mm tube

Solvent Addition:                      0.02 mL to 12 mL (container max working volume)

                                               Meets or exceeds USP accuracy for 10 mL transfer pipets,           configurable to nine solvents input

                                               Gravimetric data tracking using intemal balance

Filtration:                                  25 mm disposable filter (Automation Certified) per sample

                                               0.2 mL to 11.2 mL prewet volume (container max working             volume)

                                               0.2 mL to 11.2 mL collection volume (container max working        volume)

                                               200 filter capacity

Dilution:                                   1 in 1.1 to 1 in 10,000

                                               standard (concentrate transfer with diluent addition)

                                               ratiometric addition by volume

                                               ratiometric addition by mass

                                               ratiometric addition by molecular weight

Mixing:                                     Counter-rotational vortexing, with four selectable speeds   (approx. 1000, 1500, 2000, and 2500 rpm) and settable time

                                               Re-pipetting, with selectable volumes, speeds, and number of      cycles

Analysis:                                  HPLC injection:

                                               Fixed 20 uL loop standard

                                               Loop size range: 10 uL to 5.0 mL

                                               1 to 10 extemal standards

                                               Analog switch closure interface (standard) or

                                               Accessory: Interface for Waters Millennium32 V3.2            Chromatography Data System (see NOTE)

                                               UV/Vis:

                                               Sample output to flow cell

                                               Accessory: Interface for Agilent UV/Vis Advanced Mode     ChemStation Version A07.01 for the HP8453 (see NOTE that                                                follows)

Data Tracking:                         Integral IBM-compatible PC

                                               SQL Server 7.0 database for all raw data and event storage          Excel workbook file for easily viewing all raw data

                                               Accessory: Advanced Data Channels software is available to       output user­selectable data to multiple database tables via                                           ODBC, multiple Excel files, or multiple ASCII files

Robotic Handling:                    Four-axis robot with grip that senses tubes, containers, and 25     mm filters only Software-driven positions adjustment

                                               Rotary displacement: 235 degrees

                                               Reach displacement: 13.54 in. (34.4 cm)

                                               Vertical displacement: 13.39 in. (34.0 cm)

                                               Grip displacement: 1.3 in. (3.3 cm)

PC/Controller:                         US version Windows NT 4.0 Service Pack 5 or 6 (or later) (see    NOTE below)

                                               Microsoft Excel 2000

                                               Microsoft Internet Explorer 5.0

                                               Hard drive with 4.OGB minimum free space

                                               64MB RAM minimum

                                               CD-ROM: 24X minimum speed

                                               Intel processor: 266 MHz minimum

                                               Serial port (1) 16550C compatible

                                               Video: 2MB VRAM, 256 colors, 1024 x 768 resolution Instrument Disk Drive         720K DSDD only

                                               Used for booting instrument only; contains no raw data

Performance Specifications

The following specifications apply to the liquid handling ^a performance of the Prelude Workstation using 16mm test tubes, operäting under default parameters and conditions specified with each section, and using degassed, DI water at 25° C.

Solvent Addition using             Volumes from 0.5 mL to 9.6 mL:

10mL standard syringe:          Accuracy: ±30 uL

                                               Precision: ± 30 uL

Solvent Addition using 1mL     Volumes from 0.05 mL to 1.0 mL:

Internal Standard Syringe:       Accuracy: ± 10 uL

                                               Precision: ± 10 uL

Transfer using 10mL               Volumes from 0.5 mL to 9.6 mL:

syringe:                                    Accuracy:        ± 100 uL

                                               Precision:        ± 50 uL

Density Determination:           When using at least 8 mL:

                                               Accuracy: 1.25%

                                               Precision: 0.5%

Dilution:                                   Single dilution operation involving dilution ratios up to 1 in 100        and having solution volumes > 2.0 mL and concentrate volumes                                  between 0.08 mL and 0.9 mL:

                                               Accuracy: 0.5%

                                               Precision: 0.5%

HPLC Injection:                       Loading 0.5 mL loop volume for subsequent HPLC injection:

                                               Accuracy:        100 uL

                                               Precision:        25 uL

Balance Performance:            These specifications apply when the Prelude Workstation is         installed in a mechanically stable, draft-free environment                                                suitable for 4-place or 5-place weighing, respectively, and that:

                                               • An anti-static device, operating within its expiration date,     has been installed in the balance enclosure.

                                               • The balance has been powered on for at least one hour.

                                               • The balance has been calibrated (internally) once the                       conditions listed above have been met.

                                               • The balance filter settings are set to default settings, or better.

4-Place Weighing ^b (0.1mg):   See specifications for the Mettler SAG-204 analytical balance or   the SAG-285 analytical balance in 4-place mode:

                                               Capacity Range:       >81 g to <210 g      <81 g

                                               Resolution:                1 mg                        0.1 mg

                                               Repeatability:            0.5 mg                     0.1 mg

                                               Linearity:                    ± 1 mg                     ± 0.2 mg

5-Place Weighing ^b (0.01mg):             See specifications for the Mettler SAG-285 analytical balance:

                                               Capacity Range:       >81 g to <210 g         <81 g

                                               Resolution:                0.1 mg                       0.01 mg

                                               Repeatability:            0.1 mg                       0.05 mg

                                               Linearity:                    ± 0.2 mg                    ± 0.1 mg

a. Liquid handling performance is verified using a 4-place analytical balance integral to the Prelude Workstation. Accuracy is computed as the absolute or relative deviation of the mean of 10 replicate determinations from the target value. Precision is computed as the absolute or relative standard deviation of 10 replicate determinations.

b. Balance performance at location will vary depending on environmental conditions and filter settings. Zymark testing has confirmed Mettler's reported specifications for weights greater than 60 mg.

Physical Specifications

Sample Tubes:                        Borosilicate glass

Tube Caps:                             Polypropylene

Tube Racks:                            Four, 50-position, 16 mm sample tube racks, Teflon-coated

HPLC and UV Standards        One, 10-position, 16 mm standards tube, Teflon coated

Rack:

Sonicator:                                3 mm probe, Titanium alloy

                                               1/16 inch SS thermocouple probe

Filter Holder:                            Slip luer per ANSI Z70.1-1955, KEL-F fittings

Filter Type:                              Membrane, 25 mm, Automation Certified

                                               ANSI Z70.1-1955 slip luer compliant

                                               Consult Zymark for list of compatible types

Syringes:                                 Liquid handling: 10 mL, guided

                                               Air push: 5 mL, silicone-lubricated (Dow 66)

                                               Intemal Standard: 1 mL

                                               Waste: 10 mL, guided

Three-Way Valves:                 Solenoid-actuated

                                               All Teflon

                                               0.028 in. (0.71 mm) diameter equivalent port clearance

Twelve-Port Valve:                  Stepper motor driven, rotary

                                               Passivated 316 stainless steel rotor and stator

                                               Proprietary Teflon seal

                                               0.048 in. (1.22 mm) diameter port clearance

Tubing:                                    Teflon, 0.030 in., and 0.055 in. ID

Fittings:                                    For 0.055 in. ID Teflon tubing: zero dead volume

                                               KEL-F inserts with non-wetted Viton 0-ring and Teflon        compression screws

Cannulas:                                Liquid handling: 0.040 in. ID, passivated 304 stainless steel

                                               HPLC sipping: 0.023 in. ID, passivated 304 stainless steel

Dimensions:                            Workstation without PC Controller:

                                               29.5 in. (75 cm) tall, not including filter tubes

                                               24 in. (61 cm) wide

                                               35 in. (89 cm) deep

                                               Workstation with Sonication or Extended Rack Accessory:

                                               29.5 in. (75 cm) tall, not including filter tubes

                                               36 in. (91 cm) wide

                                               35 in. (89 cm) deep

                                               Controller with Monitor & Keyboard: Industry standard, mini-           tower or desktop. Typical:

                                               19 in. (48 cm) tall

                                               23 in. (58 cm) wide

                                               22 in. (56 cm) deep

Weight:                                    1671bs. (76 kg) Instrument and Controller, without Extended         Rack or Sonicator Station accessories

Power:                                     100, 120, or 240 VAC ± 10%

                                               50 - 60 Hz

                                               240 VA Maximum includes controller

Fuses:                                     100/120 volts: 3.0amps, type T, voltage 250

                                               240 volts: 1.6amps, type T, voltage 250