VALIDATION ASSESSMENT OF A WATER TREATMENT SYSTEM IN THE PRODUCTION OF A PHARMACEUTICAL SUBSTANCE WITH ANTIMICROBIAL POTENTIATING ACTIVITY

Received: 19 August 2026

Accepted: 01 October 2026

Published online: 30 October 2026

UDC: 615.014.8:628.16

DOI: 10.53511/pharmkaz.2026.5.11

Article type: Original Research Article

 

VALIDATION ASSESSMENT OF A WATER TREATMENT SYSTEM IN THE PRODUCTION OF A PHARMACEUTICAL SUBSTANCE WITH ANTIMICROBIAL POTENTIATING ACTIVITY

 

Zhassur Taganov¹, Suiin Yenglik¹, Ardak Jumagaziyeva¹,
Roza Karzhaubayeva¹, Kairat Zhakipbekov², Anel Azamatova¹, Daniil Shepilov¹, Zhanturiyev Bolat³, Amirkan Azembayev¹

¹JSC “Scientific Center for Anti-Infectious Drugs”, Almaty, Kazakhstan

²Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan

³Biological Testing Laboratory of the Testing Center (Almaty Territorial Branch),

National Center for Expertise of Drugs and Medical Devices (NCED), Almaty, Kazakhstan

 

Introduction. Purified water is one of the most important technological utilities in pharmaceutical manufacturing and is widely used in the synthesis of pharmaceutical substances, preparation of technological solutions, equipment sanitation, and production processes. The stability of its physicochemical and microbiological characteristics directly affects the quality, safety, and reproducibility of pharmaceutical products. Therefore, qualification and validation of water treatment systems are essential requirements of Good Manufacturing Practice (GMP).

Objective. To evaluate the efficiency of a water treatment system and to confirm the stability of purified water quality parameters during qualification and validation at a pharmaceutical manufacturing facility.

Materials and Methods. The study was conducted at the pilot production facility of the Scientific Center for Anti-Infectious Drugs JSC. Prior to validation, Installation Qualification (IQ) and Operational Qualification (OQ) of the water treatment system were performed. Validation was carried out through Performance Qualification (PQ) over a 12-month period. Drinking water was analyzed for organoleptic properties, pH, nitrates, chlorides, sulfates, dry residue, and total microbial count. Purified water was evaluated for conductivity, nitrates, heavy metals, oxidizable substances, and microbiological purity. All analyses were performed in accordance with the State Pharmacopoeia of the Republic of Kazakhstan and internal quality control procedures.

Results. IQ and OQ confirmed compliance of the water treatment system with technical and operational requirements. During PQ, drinking water parameters complied with sanitary standards despite seasonal variations in individual physicochemical and microbiological indicators. The pH values ranged from 6.68 to 7.45, nitrate concentrations from 0.37 to 2.60 mg/L, and total microbial counts remained within acceptable limits. Purified water demonstrated high stability throughout the observation period. The electrical conductivity values ranged from 120.8 to 128.5 µS/cm for drinking water and from 0.59 to 1.53 µS/cm for purified water, and complied with pharmacopeial requirements. Nitrates, heavy metals, and oxidizable substances complied with established specifications, while no microbial contamination was detected.

Discussion. The stability of the physicochemical and microbiological parameters of purified water over 12 months indicates the effectiveness of combining reverse osmosis with deionization. Seasonal variations in the quality of incoming drinking water were not accompanied by deterioration in purified water quality, supporting the system’s operational stability under the conditions studied. The absence of detected microbial contamination highlights the importance of sanitary control and routine monitoring in maintaining the validated state of the system.

Conclusion. The performed qualification and validation confirmed the efficiency of the water treatment system and its ability to consistently produce purified water of stable quality regardless of seasonal variations in the source drinking water. The sequential purification scheme combining reverse osmosis and deionization effectively removes dissolved and microbiological contaminants and supports maintenance of the validated state of the system during long-term operation.

Keywords: purified water; water treatment; qualification; validation; IQ; OQ; PQ; reverse osmosis; deionization; GMP; pharmaceutical manufacturing.

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