Tender Details

Country: USA
Summary: Retrofit Glatt GCG 70 Dry Mixer for signal exchange to third party equipment
UST Ref No: 123056876
Deadline: 01 Aug 2025
Financier: Self Financed
Purchaser Ownership: Government
Tender Value: Refer Document
Notice Type: Tender
Document Ref. No.: FDA-RFQ-25Q1283892
Purchaser's Detail:
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Description:
Description
Background
The Office of Pharmaceutical Quality Research (OPQR) supports the modernization of pharmaceutical manufacturing by conducting regulatory science research on emerging technologies. Continuous manufacturing (CM) of oral solids has been recognized as an emerging technology by the FDA. Continuous process monitoring and manufacturing process control are critical for establishment of a robust CM process that can consistently produce product of desired quality, while identifying and mitigating manufacturing risks.
Currently, OPQR possesses a Glatt GCG 70 continuous dry mixer. However, the GCG 70 lacks the capability to communicates with other equipment or systems. To integrate the GCG 70 into a CM line, a retrofit is required to enable it to interface with a supervisory control system. This upgrade will enhance the functionality of the GCG 70.
This package includes both hardware and site services for retrofitting the GCG 70 dry mixer to facilitate signal exchange with other equipment. The retrofitted GCG 70 should be adaptable to CM operation which includes options for the seamless integration of upstream and downstream unit operations. It will also enable synchronized control of process parameters of other unit operations through automatic modulation.
This retrofit is essential to support the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) review processes for CM applications.
Scope
To retrofit the GCG 70 Dry Mixer to communicate with the other equipment of systems.
Requirements
The GCG 70 retrofit shall meet the following salient characteristics:
Shall enable electronic communication with SIMATIC PCS 7 distributed control system for integration with other equipment. Shall enable setting blender speed remotely, including start/stop, as well as feedback indicating that the blender is running and the actual speed. Shall not restrict or inhibit any existing operational capabilities of the...
Documents:

Combined-Synopsis-for-GCG-70-Dry-Mixer.pdf

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Retrofit Glatt GCG 70 Dry Mixer for signal exchange to third party equipment - USA Tender

The HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION, a Government sector organization in USA, has announced a new tender for Retrofit Glatt GCG 70 Dry Mixer for signal exchange to third party equipment. This tender is published on USARFP under UST Ref No: 123056876 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2025-08-01.

The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.