MDTL offers water system validation studies  as per the applicable standards  and can also create individual customized testing strategies. Water tests are used to evaluate microbial content and chemical purity of water samples. Because water is a significant environmental component, microbial control is a requirement of all Good Manufacturing Practices. Tests can be performed on source water, process water, purified water, deionized water, and highly purified water. Routine monitoring of the water system is also recommended to ensure ongoing compliance with the manufacturer’s acceptance criteria and bioburden monitoring programs.

MDTL will customize water tests to meet the precise needs of the sponsor. Our Technical Consulting team can also assist in writing IQ/OQ/PQ protocols for initial water system qualifications and related validations, sampling plans, test frequency determination, and failure investigations.