Calibration and qualification of HVAC systems Tender - 81811072

Procurement Summary

Country: Rwanda

Summary: Calibration and qualification of HVAC systems

Deadline: 25 Apr 2023

Posting Date: 19 Apr 2023

Other Information

Notice Type: Tender

TOT Ref.No.: 81811072

Document Ref. No.:

Competition: ICB

Financier: Self Financed

Purchaser Ownership: Public

Tender Value: Refer Document

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Tender Details

Tenders are invited for Calibration and qualification of HVAC systems
Qualification of its Hvac System.
1. Description of the offers:
- Calibration and qualification of HVAC systems (4 systems)
- Calibration and qualification of 2 HFL (1 HFL for sampling and 1 HFL for weighing)
- Calibration, qualification and characterization under vacuum and under load of the positive cold room
- Commissioning and empty and load mapping of the 2 storage warehouses (MP-AC and PF)
- Qualification of the compressed air system;
This involves meeting the normative requirements relating to the qualification of equipment and installations, namely
- The guide to Good Manufacturing Practices, in particular in appendix 15 of the GMPs
- Standard NF 14644-1 classification of air cleanliness by particle concentration
- WHO Guide No. 937_Annex 2 additional guidance on good practices for HVAC systems related to the manufacture of pharmaceutical products in non-sterile dosage forms
- The requirements of standard N 15 140 relating to climatic and thermostatic chambers
- WHO Technical Report Series, No.961, 2011
- Annexe 9 : "Model guidance for the storage and transport of time- and -temperature-sensitive pharmaceutical products"
- Supplement 8: "Temperature mapping of Storage areas" May 2015 (WHO Technical Report Series No. 961.2011).
[Disclaimer: The above text is machine translated. For accurate information kindly refer the original document.

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