Attachment C_Bill of Materials for RFQSSPR459571.pdf

Item Country of Origin Commodity Code Manufacturer Quantity Part Number Description

1 Bruker Scientific LLC

1 A250/DII ALPHA II FT-IR Spectrometer.

2 Bruker Scientific LLC

1 A220/D-01HP Platinum-ATR Universal sampling module, diamond, 1 bounce, high pressure.

Bruker

Scientific LLC 1 C295-W/D

WLAN-Adaptation, for wireless operation of the ALPHA spectrometer, including mount and power-connection to ALPHA (Operation of device might be restricted in countries outside the EU).

Bruker

Scientific LLC

1 O/IR9+

OPUS/IR, FT-IR Spectroscopy Software Package version 9: newest released OPUS version 9.x for this spectrometer type. OPUS is integrated software for the acquisition, processing, evaluation and reporting of IR-spectroscopic data in laboratory and process environments and is compliant with cGMP/GLP/GAMP regulations such as 21 CFR Part 11 and the FDA data integrity guideline. OPUS is validated software and supports the validation of the spectrometer: - Fully automated test routines for operational and performance qualification (OQ, PQ) - Permanent instrument status indicator, online monitoring of system performance / OPUS is compliant with cGMP/GLP: - Multi level user management, log-in with user name and password, separated administrative and measurement /evaluation functionality - Audit trail (history log function) of system and user, spectra, measurement parameters and evaluation methods - Data integrity mode (ALCOA principle) with protected data pool (OPUSNALIDATION required) - All data, incl. manipulation and evaluation results, stored in ONE file - Electronic signature of spectra and methods; 21 CFR Part 11 compliance (OPUSNALIDATION required) / OPUS supports user during daily routine work: - Run, create and edit macros and VB scripts - Automated execution of repeated actions via calendar - Lab journal functionality - Online help - Multimedia FT-IR tutorial.

This OPUS software package is included in the standard delivery of the spectrometer system.Note: 32 Bit Microsoft Office versions are not compatible with OPUS 9 and must not be installed on the same computer. Bruker does therefore take no liability for this unsupported software combination.

Bruker

Scientific LLC

1 0/TOUCH+

OPUS-TOUCH software for intuitive and convenient IR-analysis in routine and R & 0 Newest released version for this spectrometer type / OPUS-TOUCH provides an indicator that informs the user about the current overall system status. Detail info from the online diagnostics of all vital spectrometer components is shown in the device monitor. It also gives an overview about the validity of the spectrometer's operational and performance qualification (OQ, PQ). If needed the fully automated instrument test routines are directly started. OPUS TOUCH can be utilized in regulated pharma environment in compliance with cGMP. Required: - ALPHA, MOBILE-IR 11, INVENIO or VERTEX spectrometer- OPUS 9.0 or higher - Touch panel computer, or notebook, or desktop pc. Recommended CS86-x touch panel pc for the spectrometer permitting highest level of soft- and hardware integration, alternatively CS85/x external computer.

6 1 Tariff Surcharge Tariff Surcharge

- OR Domestic Equivalent -

ALPHA FT-IR Spectrometer, ALPHAII-P, ALPHA II - Platinum FT-IR Spectrometer with Platinum Diamond-ATR QuickSnap Sampling Module. The ALPHA II - Platinum includes the Platinum-ATR Universal sampling module that facilitates the analysis of virtually any liquid and solid sample, independent from its shape and composition. For most samples the measurement is performed without sample preparation and without the need of any consumables. To record the IR-spectrum any sample just has to be brought into contact with the ATR measurement interface. Next to powders and films the universal high pressure clamp even allows the analysis of particularly hard specimen, like polymer pellets/ granules, andvaria�yshapedparts. Measurement times are typically below 1 minute. The measurement interface of the ALPHA-Platinum is a diamond ATR crystal with a very high mechanical and chemical robustness. Therefore, the Platinum-ATR sampling module has a lifetime of >10 years. A wide range of QuickSnap sampling modules is available for the ALPHA 11, providing a perfectly matching measurement setup for a large variety of samples and applications. With the push of a button, the exchange of the sampling modules is performed quickly and easily. The PermaSure function automatically recognizes each change of the setup and performs a quick self-test ensuring a proper instrument performance. Suitable measurement settings for the used configuration are automatically loaded. The PerformanceGuard continuously monitors the spectrometer electronics as well as optical and mechanical components to permanently assure the correct functioning of the complete instrument. The ALPHA II fulfills all requirements to be used according to the demands of Good Laboratory Practice (GLP). Further validation options are available allowing operation of the ALPHA II in full compliance to cGMP/GMP, US, European and Japanese Pharmacopeia and 21 CFR Part11. The included Bruker ATR-IR library "BPAD" is a helpful tool for identification of unknown material in daily routine analysis. The library includes a collection of mid-lR reference spectra of basic polymers and plastics. / System specifications: - Compact ALPHA II FT-IR spectrometer with diamond-ATR measurement interface - Robust metal housing - Small footprint: 22x30cm (including sampling module) - Weight: approx. 7kg - Spectral range: 350-8,000cm-1 (ALPHA II base spectrometer) - Spectral resolution: better than 2cm-1; option: better than 0.75cm-1 - RockSolid interferometer: gold mirrors, high throughput, permanent alignment, long life time >10 years - Diode laser, high wavenumber accuracy and precison, long life time >10 years - IR-Source: CenterGlow technology for continuously optimized light flux, long life-time > 5 years. - Detector: DTGS, temperature-controlled, high stability against external temperature changes - Sealed and desiccated optics - Internal validaƟon unit (IVU) with reference standards for automated instrument tests of every ALPHA II setup and every measurement mode - Automated instrument tests for operaƟonal and performance qualificaƟon (OQ; PQ) -Easy exchange of ALPHA QuickSnap sampling modules - PermaSure: Automatic recognition and individual calibration of QuickSnap modules and ATR-crystal plates, automatic performance test and load of appropriate measurement parameters when changing the configuration - PerformanceGuard: continuous monitoring of all spectrometer components, performance and humidity. - Validated OPUS-TOUCH software, prepared to work fully compliant to GLP and GMP regulations - Platinum-ATR Universal QuickSnap sampling module with diamond ATR- crystal, single reflection, monolithic, edged in tungsten carbide, long life time >10years - Work disk: stainless steel - Spectral range: 350-8,000cm-1 - Slip clutch high pressure applicator - Exchangeable pressure stamps; flat surface for powders, films and shaped parts, conical surface for pellets and granules - Working distance (max. sample height) 20mm - Perfect for analysis of large samples: approx. 350° free working area around crystal. - Easy cleaning due to 360° rotation of pressure applicator / Included: -BPAD BRUKER ATR Polymer Spectra Library, 234 spectra (of 117 polymers) recorded with diamond- and germanium-ATR technique. - O/TOUCH+ OPUS-TOUCH software for intuitive and convenient IR-analysis in routine and R & D - Desiccant - Set of tools / Portability options: - S201/D Carrying case for ALPHA FT-IR spectrometer - S202/D Trolley for ALPHA FT-IR spectrometer or S202/DII Trolley for ALPHA II FT-IR spectrometer with integrated touch panel CS86-A+ - C295-W/D WLAN-Adaptation, for wireless operation of the ALPHA FT-IR Spectrometer / Required: - Computer, recommended: CS85/27+ MS Surface PC and C27-TH integrated tablet holder, or CS86-A+ integrated touch panel computer, or CS81/25+ Data system, Ultra Slim desktop.

Bill of Materials for RFQSSPR459571