Validation of Utility Systems in Pharmaceutical Facilities 

Many types of utilities are utilized in pharmaceutical producing facility. it's vital and obligatory to validate the utilities before its use in pharmaceutical producing.

This chapter provides a outline of the key validation check functions and acceptance criteria for every utility system. These ar provided as a suggestion for those concerned within the validation of fundamental principle Pharmaceutical. Approval of this program neither provides approval of those check functions and acceptance criteria nor will it limit the check functions and acceptance criteria enclosed in any protocol. Final approval of check functions and acceptance criteria is formed by approval of the Installation, Operational, and wherever applicable, Performance Qualification protocols.

A. Plant Steam

Test Functions 

1. Perform Installation Qualification of deionizer and distillation instrumentality, holding tanks, clean steam generator, and distribution system. 

2. Complete and document all needed pre- start-up maintenance procedures (including cleaning). 

3. Perform general operational controls verification testing. 

4. Operate system throughout the vary of operative style specifications or vary of supposed use.

5. ensure that the pressure-reducing regulators in preset operative pressure ±2 psi. 

6. Verify that the system has adequate steam capability throughout peak hours of operation. ensure that the steam pressure is inside five psi of the counseled operative pressure. 

7. Record the vary of all process/ instrumentality parameters (set points, pressure, temporal order sequences, etc.) verified throughout operational and performance qualification testing. 

8. check the water created by the system to confirm adequate physical phenomenon. 

9. ensure the holding tank water quality doesn't modification adversely throughout storage in holding tanks.

Acceptance Criteria 

1. The system is put in in accordance with style recommendations, and CGMPS. Instruments ar specifications, manufacturer graduated, identified, and entered into the standardization program. 

2. General controls and alarms operate in accordance with style specifications. 

3. The system operates in accordance with style specifications throughout the operative vary or vary of supposed use. 4. System regulators should operate inside ±2 psİ of style levels. 

5. The system capability should be ample to control all systems at peak demand periods.

B. Pure Steam 

Test Functions 

1. Perform Installation Qualification. Perform general verification testing. 

2. operational controls. 

3. Operate system throughout the vary of operative style specifications or vary of supposed use. 

4. Verify that clean steam is fed by a refined water system or WFI system. 

5. ensure that the pressure-reducing regulators within the sub-branches ar set at the preset operative pressure ±2 psi. 

6. Verify that the system has adequate steam capability throughout peak hours of operation. ensure that the steam pressure is inside five psi of the counseled operative pressure. 

7. Operate the system per applicable SOPS. per the sampling Perform sampling as procedure condensation samples for agreement to current USP Water for Injection treatise (also toxin, sterility). 

8. Record the vary of all process/ instrumentality parameters (set points, pressure, temporal order sequences, etc.) verified throughout Operational and Performance Qualification testing.

Acceptance Criteria 

1. The system is put in in accordance with style recommendations, and CGMPS. Instruments ar graduated, identified, and entered into the standardization program. specifications, manufacturer. 

2. General controls and alarms operate in accordance with style specifications. 

3. The system operates in accordance with style specifications throughout the operative vary or vary of supposed use. 4. The system capability should be ample to control all systems at peak demand periods. 

5. Operate the system per applicable SOPS. Perform sampling over a 1-month amount as per the sampling procedure and schedule. check samples for agreement to current USP Water for Injection treatise. 

6. All samples should meet the subsequent criteria:

• Chemical checking: Test samples should meet the acceptance criteria of the chemical tests as delineate in USP twenty four treatise on Water for Injection. 

• medicine Purity: All samples should contain no quite ten cfu/100 ml; no bacteria genus or coliform is detected. 

• Endotoxins: but zero.25 EU/ml.

C. Water For Injection (WFI) 

Test Functions 

1. Perform Installation Qualification. Verify piping, fittings, correct dimensions, drawings, wiring, laptop software system, standardization, and quality of materials. 

2. Check flow rates, low volume of water, excessive pressure drop, impedance drops below- point, and temperature drop or increase on the far side a group level. 

3. Perform general operational controls verification testing. 

4. Operate system throughout the vary of operative style specifications or vary of supposed use. 

5. System regulators should operate inside ±2 psİ of style level. 

6. Operate the system per applicable SOPS. Perform sampling over a 1-month amount per the sampling procedure and samples for agreement to current USP Water for Injection treatise, microbic content, and toxin content. determine all morphologically distinct colony forming units (CFUS) to a minimum of the genus level. 

7. live the rate and calculate the speed of the water, or live the speed directly at purpose|some extent|a degree} between the last use point and also the tank.

8. Record the vary of all process/ instrumentality parameters (set points, flow rates, temporal order sequences, concentrations, etc.) verified throughout Operational and Performance Qualification testing. 

Acceptance Criteria 

1. The system is put in in accordance with style recommendations, and CGMPS. Instruments ar specifications, manufacturer graduated, identified, and entered into the standardization program. 

2. General controls and alarms operate in accordance with style specifications. 

3. The system operates in accordance with style specifications throughout the operative vary or vary of supposed use. 4. The system rate should be in compliance with style specifications. 

5. All samples should meet the subsequent criteria:

• Chemical checking: Test samples should meet the acceptance criteria of the chemical tests as delineate in USP twenty four treatise on Water for Injection. 

• medicine Purity: All samples should contain no cfu/100 ml; no bacteria genus or quite ten coliform is detected. 

• Endotoxins: samples contain no quite zero.25 EU/ml. All should Physical Properties: The temperature of the new Water for Injection should be larger than 80°C. 

• Particulate Matter: tiny Volume Injection: the tiny Volume Injection meets the wants of the check if the typical range of particles it contains isn't quite ten,000 per instrumentation that's adequate to or larger than ten um in effective spherical diameter and less than a thousand per instrumentation adequate to or larger than effective twenty five in spherical um diameter.

D. compressed gas 

Test Functions 

1. Perform Installation Qualification. 

2. Perform general operational controls verification testing. 

3. Operate system throughout the vary of operative style specifications or vary of supposed use. 

4. Verify that the compressed gas system is capable of provision controlled compressed gas to any or all use points. Perform associate operational check of the distribution system and pressure regulators by watching the pressure output at the various use points. 

5. Perform a capability check to verify that the system is capable of provision the desired gas, pressure, and rate at every use purpose. 

6. Verify that in-line filters ar integrity tested. ensure that each one documentation clearly indicates acceptable check results. 

7. Perform saturation point activity. 

8. Perform organic compound content activity. 

9. Perform viable particulate count, microbiological at important use points when sterile filters (refer to Federal commonplace 209E). 

10. Identification of chemical element content.

Acceptance Criteria 

1. The system is put in in accordance with style recommendations, and CGMPS. Instruments ar specifications, manufacturer graduated, identified, and entered into the standardization program. 

2. General controls, alarms, and interlocks style in accordance with operate specifications. 

3. The system operates in accordance with style specifications throughout the operative vary or vary of supposed use. 4. The compressed gas distribution system systematically deliver controlled compressed gas to the utilization points at the look pressure as such. 

5. All in-line filters ar integrity tested and qualify specifications.