Mission Vivacare Ltd.

Pharmaceutical Water

Poorvesh PancholiMicrobiology Section

Quality Control Mission Vivacare Ltd.

Water – The Essential Fluid

• For:• Municipal, residential, commercial,• institutional, industrial

• Focus on industrial:• Chemical, petrochemical, refining, pulp and• paper, power, food and beverage,• pharmaceutical, and semiconductor• manufacturing• Water can be used as a utility, a reactant, or a

raw material

Water – The Essential Fluid

Types of Water1. Raw or Source Water2. Potable or Drinking Water3. Purified Water4. Water for Injection5. Water for Hemodialysis6. Pure Steam7. Sterile Water (Purified, WFI etc)

Pharmaceutical Water

Three Major Aspects

Pharmaceutical Water

Regulatory Aspects:No. of Regulatory Guidelines direct the

Acceptance criteria, Some are:1. US-FDA2. EU3. WHO4. ISO5. BIS6. US-EPA 7. ICH

Pharmaceutical Water

Engineering Aspects: In Mission Vivacare, we are having

Water Generation and Distribution system, which complies the overall requirement of Pharmaceutical Water. Our system is having number of different components which are consistently producing the desired Quality of Purified Water

Water Generation System(In General)

Water Generation System

Bore-well

AKVN supply

Water Generation System

Water Generation System

Osmotron System

User Points

Water System Qualification is going on in our Industry, which comprise at least but not limited the following

1. Design Qualification

2. Installation Qualification

3. Operational Qualification

4. Performance Qualification

Our QC unit having the SOP’s, Spec’s, STP’s, GTP’s etc for Sampling and analysis of Water, which have been prepared and approved by well trained qualified peoples .

The references have been taken from various Regulatory authorities.

• General qualitative description of water Color, odor, clarity

• Quantitative measurements of water quality pH – hydrogen ion concentrationORP – oxidation-reduction potential Conductivity – total ionic concentrationDissolved oxygen – specific applicationsTOC – Total Organic Carbon

Water Quality – Measurement Tools

• pH, ORP, Conductivity, DO, TOC

Probe , electrodes based upon potentiometric methods

Devices used must be adapted to meet ANSI/ISA 76.00.02

Purified Water must be free from Specified Objectionable Microorganism viz.

1. E.coli

2. Salmonella

3. P.aeruginosa

4. S.aureus

Total Aerobic Microbial Count (TAMC) Limits for different grade of waters

are as follow:

1. Raw Water- NMT 500 CFU/ml

2. Process Raw Water- NMT 500 CFU/ml

3. Potable Water- NMT 500 CFU/ml

4. Purified Water-NMT 100 CFU/ml

Our system is having 24 Hrs. re-circulation of purified water,

which prevent the generation of Biofilms. The system is free from the dead legs. Sampling techniques applied here are

made to prevent any environmental contamination.

Sanitization of the System

Microbial control in water system is achieved primarily through sanitization practices. System can be sanitized using either Thermal or Chemical means.

Thermal approaches to system sanitization include periodic or continuously circulation of hot water and the use of steam.

Sanitization of the System

Although the Thermal approach of sanitization control the generation of Biofilm, they are not effective in removing established Biofilms. Killed but intact Biofilm may serve as a nutrient for upcoming Microbes within the system and they can form a new Biofilm, if the sanitization condition removed or halted.

Sanitization of the System

In such cases a combination of routine Thermal and periodic supplementation with chemical sanitization would be more effective.

Chemical methods, where compatible can be used on a wider verity of construction material.

Sanitization of the System

Chemical methods typically employ oxidizing agents such as Hydrogen peroxide, Ozone, peracitic acid or combination thereof.

These chemicals oxidize bacteria and Biofilms by forming reactive peroxides and free radicals.

Operation, Maintenance and control

A preventive maintenance program should be established to ensure that the water system remain in the state of control. This program should include:

1. Procedure for operating the system

2. Monitoring Program for critical Quality Attributes

3. Approved schedule for Sanitization

4. Preventive maintenance of the components

5. Control of changes in operation

Conclusion

The system installed over here is consistently producing the water which is meeting with the regulatory requirements.

Pharmaceutical Water

Questions??

Pharmaceutical Water

Thank You