PRODUCTS 10 The cleaning or biocleaning process includes the possible use of detergents. Annex I of the GMP, in chapter 4.36, states: Clean rooms must be thoroughly cleaned and disinfected in accordance with a written document. For disinfection to be effective, cleaning must be carried out beforehand to remove contamination from surfaces This detergent is low-foaming, pH-neutral, ready-to-use, sterile or non-sterile. hReady-to-use multi-purpose detergent for high surfaces and floors/wall/ceilings hpH 7.5 +/- 0.5 hPlant-based surfactants hEcoDetergent: 99 ,9% of ingredients of natural origin hWithout hazard pictograms hUnscented hBatch traceability hSterile version: - Double individual packaging - Sterilisation by gammairradiation at a minimum of 25 kGy - SAL10-6 - Sterility certificate supplied PureDTU detergent PureDTU detergent WATER Part no. Packaging Sterile Units/ box € excl. tax/box 838702 1 L sprayer No 12 NC - According to GMP Annex I (chapter 5.4): The cleaning programme should be validated to: i. Remove any residues or debris that could limit the effectiveness of the disinfectant used; ii. Minimise chemical, microbial and particulate contamination of the product during the process and before disinfection. A rinsing phase may therefore be necessary. This can be done with water or alcohol, which leaves no residue on surfaces. In classes A and B, sterile water is recommended. OTEC Aguettant sterile apyrogenic water has MPUP status (Raw Material for Pharmaceutical Use, except for injectable, ophthalmic and inhaled products): - Complies with the NF EN ISO 3696 type 3 standard - Monograph "Purified water in containers" from European Pharmacopoeia. - Monography "sterile purified water" from USP. hBatch traceability hCertificates of analysis and sterility supplied Sterile non-pyrogenic water Part no. Designation Units/box € excl. tax/box 069802 Sterile water 1L non-pyrogenic (on pallet) 550 NC - 069802A Sterile water 1L non-pyrogenic 1 NC - 069805 Sterile water 5L non-pyrogenic (on pallet) 75 NC - 069805A Sterile water 5L non-pyrogenic 1 NC - OTEC water
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