On site installation diagram of pharmaceutical purified water equipment

GMPThe requirements for pharmaceutical purified water equipment are as follows:

2010Pharmacopoeia Requirements:

2010The pharmacopoeia has strict requirements for the quality of purified water, and the relevant regulations are as follows:

1）Overall characteristic requirements: This product is a colorless, odorless, and tasteless clear liquid made from drinking water by distillation, ion exchange, reverse osmosis, or other suitable methods, without any additives.

2）Quantifiable indicator: conductivity ≤2MS/cm (Electrical resistivity ≥0.5 MΩ.CM)

3）Other inspection indicators:

酸碱度：取本品10mlAdd methyl red indicator solution2Drip, do not show red color; take separately10mlBromothyroxine blue indicator solution5Drip, do not show blue color

nitrate:Take this product10mlPlace it in a Nessler's tube and add a dilute hydrochloric acid solution of p-aminobenzenesulfonamide(1→100)1mlSolution with Naphthalene Ethylenediamine Hydrochloride(0.1→100)1mlThe pink color produced is consistent with the standard nitrite solution[Take sodium nitrite0.750g(Calculated by dry product)Dissolve in water and dilute to100mlShake well and measure accurately1mlDilute with water to100mlShake well and measure accurately1mlDilute with water to50mlShake well to obtain(each1mlequivalent to1MgNO2)]0.2mlAdd nitrite free water9.8mlCompare the colors processed using the same method and do not make them darker(0.000002%).

nitrite:Take this product5mlPlace in a test tube, cool in an ice bath, and add10%solution0.4mland0.1%Diphenylamine sulfuric acid solution0.1mlShake well and slowly add sulfuric acid dropwise5mlShake well and transfer the test tube to50℃水浴中放置15Minutes, the blue color produced by the solution matches the standard nitrate solution[取硝酸钾0.163gDissolve in water and dilute to100mlShake well and measure accurately1mlDilute with water to100mlMore precise measurement10mlDilute with water to100mlShake well to obtain(each1mlequivalent to1MgNO3)]0.3ml,Add nitrate free water4.7ml,Comparison of colors processed using the same method,Cannot go deeper(0.000006%).

ammonia:Take this product50mlAdd alkaline potassium test solution2mlPlace it15minute; Like color development, with ammonium chloride solution(Take ammonium chloride31.5mgAdd an appropriate amount of ammonia free water to dissolve and dilute into1000ml)1.5mlAdd ammonia free water48mlCompared with alkaline potassium test solution2mlThe comparison of the prepared control solution should not be deeper(0.00003%)

oxide:Take this product100mlAdd dilute sulfuric acid10mlAfter boiling, add potassium permanganate titrant(0.02mol/L)0.10mlBoil it again10Minutes, the pink color must not disappear

Non-volatile substances:Take this product100ml, set up105Evaporate in a constant weight evaporating dish at ℃, dry on a water bath, and then105Dry to constant weight at ℃, and the residue should not exceed1mg

heavy metal:Take this product100mlAdd water19mlEvaporated to20mlCool down and add acetate buffer solution(pH3.5)2mlMake it in moderation with water25mlAdd thioacetamide test solution2mlShake well and place2Minutes, compared to standard lead solution1.0mladd water19mlCompare the colors processed using the same method and do not make them darker(0.00003%)

microorganism:Take this product, treat it with membrane filtration method, and inspect it according to the law(Appendix XIJ)The total number of bacteria, mold, and yeast per unit1mlNot allowed to pass100a

Shanghai Binrun SupplyUltrapure water equipmentafter-sales serviceservice

1. Warranty commitment: The product is covered by a one-year warranty from the date of successful debugging. If the product is not caused by human factors during the warranty period, it will be repaired free of charge.

2. Debugging commitment: After the water production equipment provided and installed has been installed and passed on-site pressure testing and debugging, it can only leave the site with the consent and signature of the representative of the demander.

3. Training commitment: Technical personnel can be sent to assist and guide installation and debugging according to the requirements of the demand side; During the trial operation, train the relevant operators of the demand side until the product operates normally.

4. Repair commitment: In case of equipment malfunction, on-site service will be provided within 12-24 hours upon receiving notification.

5. Lifetime commitment: After the product warranty period ends, we will provide you with lifetime service and paid accessories.

6. Accessory commitment: We can provide timely and complete accessory services both inside and outside the warranty period.