Water Purification in Pharmaceutical Manufacturing
In this assignment an overview of water purification in pharmaceutical manufacturing will be briefly explored. The system(S)/equipment used in that process will be identified and installation qualification and operational qualification of this equipment will be discussed.
As water purification is one of the crucial process in pharmaceutical manufacturing understanding of what this process entail is IQ and OP. As water is used widely in pharmaceutical production either in manufacturing or cleaning and technology is always progressing to obtain the most purified form of it. Purified water is an ingredient in the manufacturing of the medication (tablets, powder etc.) however it cannot be used for injection or parenteral products.
“The United States pharmacopoeia (USP), and the European pharmacopoeia (Ph Eur.)
set the high purity water standards for the pharmaceutical industry. Both the USP and
Ph Eur. work closely with the Food and Drug Administration (FDA), the European
Agency for the evaluation of medicinal products (EMEA), the pharmaceutical industry,
and the health professions, to establish authoritative pharmaceutical standards. These
standards are enforceable by the FDA and the governments of other countries, and are
recognised worldwide as the hallmark of quality. The FDA enforces current good
manufacturing practice (cGMP), as well as the current USP ”
In the pharmacopoeia there is strict specification set out for purified water (EP&USP). Purification of water could be done by distillation or reverse osmosis.
USP standards Organic < 0.5ppm TOC, Conductivity, 1.3 microS/cm at 25c in-line measurement, Endotoxin LAL no specification, Bacteria <100cfu/ml
If we look at the reverse osmosis method in purifying water it is one the most effective process for consistent supply of purified water. The principle of this method depends on applying mechanical pressure on un-purified water which pumps then pure water through semipermeable membrane (reverse osmosis membrane).
Pump applies pressure to the concentrated side (i.e. impure water) forcing molecules over to the pure side leaving impurities behind to be removed as waste.
Membrane removes 95-995 of suspended solids, bacteria, viruses, pyrogen, and molecules greater than 100daltons molecular weight. Most RO system produces 100l/h at 25c or 50 L/h at 10c. To increase the output we increase the pressure of the feed water. As there will be around 4% of ions will pass so deionisation system will be required following the purification.
Flow Reversed by application of pressure to high concentration solution
Adapted from http://www.appliedmembranes.com/Reverse_Osmosis_Systems.htm
Installation Qualification IQ
In installation qualification this should compliance with 21CFR, 210/211 GMP Annex 15. GDP is very important...