SAM #75F40126Q00201

FDA Solicitation for Automated Media Preparation Instrument for Dissolution Testing (Distek ezFill+ or Equal)

The U.S. Food and Drug Administration (FDA) Irvine Medical Products Laboratory is seeking to procure an Automated Media Preparation Instrument for Dissolution Testing, or an equivalent system matching the performance of the Distek ezFill+. - Government Buyer: - U.S. Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP) - OEMs and Vendors: - Distek (referenced as performance standard for "or equal" systems) - Products/Services Requested: - One Automated Media Preparation Instrument for Dissolution Testing - Must support automated preparation, heating, degassing, and dispensing of dissolution media - Volume dispensing range: 250ml to 1000ml - Temperature control and degassing capability - Portability and compatibility with standard U.S. electrical service - Installation and instrument qualification at the FDA site by an OEM-trained and certified field service engineer - Operator training for two users at the government site - Provision of qualification documentation and service report - Minimum 12-month manufacturer's warranty covering parts, labor, travel, technical support, and OEM-certified service - Unique/Notable Requirements: - Brand-name-or-equal solicitation referencing Distek ezFill+ performance - Installation and training must be performed by OEM-certified personnel - All deliverables (instrument, installation, training, documentation, warranty) must be included in the offer - Delivery required within 60 days of award

Description

The U.S. Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), has a requirement for the purchase, delivery, installation, operator training, and warranty support of one (1) Automated Media Preparation Instrument for Dissolution Testing. This acquisition will be conducted as a brand-name-or-equal procurement under NAICS 334516.

The instrument shall provide automated preparation of dissolution media for laboratory testing and be capable of heating, degassing, and dispensing dissolution media in accordance with the Government's minimum technical requirements. Salient characteristics include automated media preparation, precise dispensing accuracy, in-line heating, temperature control, media degassing capability, onboard programmable operation, reporting functionality, portability, compatibility with standard U.S. electrical service (115V, 50/60 Hz), and the ability to fill dissolution vessels while installed on dissolution apparatus.

The Contractor shall furnish all labor, materials, equipment, transportation, installation, operator training, warranty support, documentation, and other resources necessary to provide a fully operational system. Installation shall be performed by an OEM-trained and certified field service engineer and shall include operational verification testing. Operator training for two (2) users shall be provided at the Government site.

The Contractor shall provide a minimum twelve (12)-month manufacturer's warranty covering parts, labor, travel, technical support, and OEM-certified service. Required deliverables include the automated media preparation instrument, installation and qualification, operator training, service documentation, and warranty documentation.

Delivery shall be completed within sixty (60) days after contract award. Installation shall be completed no later than thirty (30) days after delivery at the FDA Irvine Medical Products Laboratory, Irvine, California. Final Government acceptance will occur following successful delivery, installation, operational verification, completion of training, and confirmation that the equipment meets all requirements specified in the solicitation.

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