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Purified Water and Water for Injection Testing

CTI purified water and water for injection testing services are based on the requirements of pharmacopoeia and GMP regulations in China, the United States, Europe and other countries, and performs on-site sampling and testing of water systems such as purified water, water for injection, etc. CTI has independent microbiological laboratories and chemical laboratories operating under dual systems of ISO 17025 and GMP, and provides one-stop water system validation services from plan drafting, validation implementation, and report issuance. We can also provide one-stop water system validation services from program drafting, validation implementation and report issuance.

Consulting quotation

Applicable Products

Purified water, water for injection, domestic water, etc.

Service Content

Water system program

CTI can provide a water system performance qualification (PQ) program that meets the customer's needs based on GMP regulations, national standards, industry guidelines, etc., in conjunction with the customer's quality system.

Water System Sampling

Dispatch professional samplers with sampling qualifications to implement on-site sampling in accordance with water sampling procedures to ensure that each water sample has a sampling record and a unique identification number.

Water System Inspection

Testing products	Purified water, water for injection, domestic water
Testing Standards	Chinese Pharmacopoeia, U.S. Pharmacopoeia, European Pharmacopoeia, national standards, industry standards, etc.
Compliance System	ISO 17025 and GMP dual system
Testing items	Full Inspection
Sample Requirements	Samples for microbiological tests should be placed in sterilized or disposable containers.

Water System Report

CTI issues a COA report based on the actual test results and can attach copies of all original records from the water system validation and a copy of the equipment calibration certificate.

Service Cycle

Sample delivery: conductivity test within 12 hours after receiving the sample, and other items within 24 hours.
CTI sampling samples: conductivity test within 12 hours after sampling, other items within 24 hours.

Service Advantages

Configuration: 99% of the equipments allocated to the platform are recognized as famous imported brands in the pharmaceutical industry.
Qualification: The platform operates under the dual systems of ISO 17025 and GMP, and has obtained both CNAS and CMA qualifications.
Guarantee: All testing electronic data is permanently stored; all testing paper data is stored for 6 years.

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