Ozone is an extremely fast and efficient oxidizer commonly used as a microbial disinfectant in pharmaceutical grade water systems. The main benefits of ozone as a disinfectant include the fact that:

• Ozone is extremely efficient, acting 3,000 times faster than chlorine
• Ozone is easily removed after the disinfection process is complete
• Ozone reduces residual TOC levels
• Ozone inherently reduces endotoxin levels
• Ozone oxidizes inorganic materials (nitrites, sulfides, etc.)

As a result, ozonation of pharmaceutical water systems is now the preferred method for disinfection by a number of leading pharmaceutical manufacturers.

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"Monitoring airborne particles in clean zones is not just a regulatory issue; it's a question of quality."

This case study presents early contamination detection in an established WFI and PW system through the use of on-line particle counters.

Effective 1 April 2005, Version 5.1 of the European Pharmacopoeia requires that dosage forms ofparenterals less than 100ml be inspected for liquidborne particles using an optical particle counteror, in certain case, an optical microscope. Previously the EP required particulate analysis only fordosage forms greater than 100ml. The test procedure for Small Volume Parenterals (SVPs) incontainers under 25ml has been in place within the EP for a number of years [Section 2.9.19, Test1.B] but until Edition 5.1 testing was not required for dosage forms equal to or less than 100ml. Thisrevision brings testing of European parenteral products more closely into harmony with the existingAmerican USP, Japanese JP and Korean KP regulations.