utility validation

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HVAC,AHU,VENTILATION,

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Utilities validation :

Utilities validation Presented By:- Raghav Goel (Q.A) 1412741 M.M COLLEGE OF PHARMACY, MULLANA, AMBALA A SEMINAR ON

Quality is always an imperative prerequisite when we consider any product. It becomes prime when it relates to life saving products like pharmaceuticals. Although it is mandatory from the government and regulatory bodies but it is also a fact that quality of a pharmaceutical product cannot be adequately controlled solely by pharmacopoeia analysis of the final product. :

Quality is always an imperative prerequisite when we consider any product. It becomes prime when it relates to life saving products like pharmaceuticals. Although it is mandatory from the government and regulatory bodies but it is also a fact that quality of a pharmaceutical product cannot be adequately controlled solely by pharmacopoeia analysis of the final product. INTRODUCTION

CONTENT INTRODUCTION TO VALIDATION REGULATORY REQUIRMENTS FOR VALIDATION IMPORTANCE OF VALIDATION SCOPE OF VALIDATION PHASES OF VALDATION PROCESS VALIDATION HVAC VALIDATION TEST Equipment /Facility /Utility qualification protocols :

CONTENT INTRODUCTION TO VALIDATION REGULATORY REQUIRMENTS FOR VALIDATION IMPORTANCE OF VALIDATION SCOPE OF VALIDATION PHASES OF VALDATION PROCESS VALIDATION HVAC VALIDATION TEST Equipment /Facility /Utility qualification protocols

according to iso 9000:2000 validation :- is defined as "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled". in contrast with verification, validation rather focuses on the question whether a system can perform its desired functions. this review is an attempt to prove the it as essential tool for quality management in pharmaceutical industry. :

according to iso 9000:2000 validation :- is defined as "confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled". in contrast with verification, validation rather focuses on the question whether a system can perform its desired functions. this review is an attempt to prove the it as essential tool for quality management in pharmaceutical industry.

the manufacturer must ensure; "that products will be consistently of a quality appropriate to their intended use”. the word “validation” simply means assessment of validity or action of proving effectiveness. according to euro pean community for medicinal products, validation is action of proving in accordance with the principals of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results. :

the manufacturer must ensure; "that products will be consistently of a quality appropriate to their intended use”. the word “validation” simply means assessment of validity or action of proving effectiveness. according to euro pean community for medicinal products, validation is action of proving in accordance with the principals of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.

REGULATORY REQUIRMENTS FOR VALIDATION Process validation is not only a regulatory requirement but also makes a great deal of sense from engineering as well as a business point of view Process validation is required, in both general and specific terms, by the Current Good Manufacturing Practices regulations for finished pharmaceuticals, 21 CFR parts 210 and 211. :

REGULATORY REQUIRMENTS FOR VALIDATION Process validation is not only a regulatory requirement but also makes a great deal of sense from engineering as well as a business point of view Process validation is required, in both general and specific terms, by the Current Good Manufacturing Practices regulations for finished pharmaceuticals, 21 CFR parts 210 and 211.

IMPORTANCE OF VALIDATION optimize and validate pharmaceutical productions quality assurance and cost reduction principles are Quality, safety, and effectiveness must be designed and built in to the product Quality control is the part of GMP, it is concerned with the sampling specification, testing and with organization documentation and release procedures :

IMPORTANCE OF VALIDATION optimize and validate pharmaceutical productions quality assurance and cost reduction principles are Quality, safety, and effectiveness must be designed and built in to the product Quality control is the part of GMP, it is concerned with the sampling specification, testing and with organization documentation and release procedures SCOPE Following are the area were validation can be implied : Analytical test methods, Instrument calibration, Process utility services, Raw materials, Packaging materials, Facilities, Manufacturing, Product design, Cleaning and Operators.

phases of validation phase 1: pre-validation phase Phase 2: Process validation phase Phase 3: Validation maintenance  phase :

phases of validation phase 1: pre-validation phase Phase 2: Process validation phase Phase 3: Validation maintenance  phase

phase 1: pre-validation phase which covers all activities like:- research and development, formulation, pilot batch studies, scale-up studies, transfer of technology to commercial scale batches, establishing stability conditions, storage and handling of in-process and finished dosage form, equipment qualification ,installation qualification, master production documents, operational qualification, process capability. :

phase 1: pre-validation phase which covers all activities like:- research and development, formulation, pilot batch studies, scale-up studies, transfer of technology to commercial scale batches, establishing stability conditions, storage and handling of in-process and finished dosage form, equipment qualification ,installation qualification, master production documents, operational qualification, process capability.

Phase 2: Process validation phase (process qualification phase):

Phase 2: Process validation phase (process qualification phase) designed to verify that all established of the critical process parameters are valid and that satisfactory products can be produced even under the worst case conditions.

Phase 3: Validation maintenance  phase:

Phase 3: Validation maintenance  phase Requiring frequent review of all process related documents ,including validation audit report to assure that there have been no changes ,deviations, failures modification to production process, and that all SOP’s have been followed including change control procedures. The validation team also assures that there have been no changes /deviations that should have resulted in requalification and revalidation.

PROCESS VALIDATION :

PROCESS VALIDATION It would normally be expected that process validation be completed prior to the distribution of a finished product that is intended for sale (prospective validation). Where this is not possible, it may be necessary to validate processes during routine production (concurrent validation). Processes which have been in use for some time without any significant changes may also b validated according to an approved protocol (retrospective validation) PROSPECTIVE VALIDATION (also called premarket validation) RETROSPECTIVE VALIDATION CONCURRENT VALIDATION RE-VALIDATION

Many types of utilities are validation :

Many types of utilities are validation Equip mental validation Process validation Facilities validation HVAC system validation / AHU system validation. Water system validation Cleaning validation Analytical method validation Computer system validation

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H - heating V - Ventilation AC - air conditioning Or CLIMATE CONTROL SYSTEM VALIDATION:- Documented evidence which provide a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.

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Air conditioning and refrigeration are provided through the removal of heat Process of "changing" or replacing air in any space to control temperature or remove any combination Heating is significant in maintaining adequate room temperature especially during cold weather conditions. HEATING AIR CONDITIONING VENTILATION 19/05/2012 15 HVAC SYSTEM VALIDATION

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Monitoring and control system

HVAC System Validation Tests :

HVAC System Validation Tests Air Flow Pattern

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Pre-filter fan Heating coil Cooling coil Intermediate filter Room HEPA filter Schematic Representation of HVAC system 80% 20% Mixing chamber Outside air Valve / Dampers Return air Exhaust outlet Distribution network humidifier

HVAC SPECIFICATIONS:

HVAC SPECIFICATIONS Temperature 18-23 o C Relative humidity 45% ± 5% Dry powder- 30% ± 5% Moisture sensitive drug- 5% ± 5% Air velocity 80- 120 ft/min Air f low Laminar airflow Pressure gradient 15 Pascal Particulate count (Critical area) NMT 100 particles of 0.5 µm/ft 3 Air system failure alarm (ASFA)

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User Requirement Specification Design Qualification Installation Qualification Operational Qualification Performance Qualification URS DQ IQ OQ PQ VALIDATION OF HVAC SYSTEM 19/05/2012 20 HVAC SYSTEM VALIDATION

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USER REQUIREMENT SPECIFICATION Set of Requirement by the User Items Class 100 Class 10,000 Class 100,000 No of Room 1 2 10 No of People 2 10 40 Room Dimensions(m) 5(W) ×6(L)×4(H) 8(W) ×6(L)×5(H) 7(W) ×8(L)×6(H) Temperature 22±2ºC Humidity 45±5 % Pressure Gradient 15 Pascal Minimum Air Changes/h 50 NLT 20 NLT 20

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DESIGN QUALIFICATION Purchase order Material of construction Fan, Filter, Duct, Heating coils etc Architecture design SYSTEM DESCRIPTION:- OBJECTIVE:- Verification of the conformance of the Selected components design specifications.

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INSTALLATION QUALIFICATION OBJECTIVE:- To verify that those components are included with their... Design and engineering specification Required utility Specified location Instrument and gauges SOPs

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OPERATIONAL QUALIFICATION OBJECTIVE : - To verify that the HVAC system component is perform in acceptance range without working conditioning 1. Air system balancing and Pressure differential Test 2. Evaluation of Filter test 3. Power-fail and Recovery test 4. Laminar Air flow system Air flow. Airflow Parallelism test. Test :-

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1.Air system balancing and Pressure Differential Test:- Objective:- To verify that air volume and pressure differential gradients between adjacent environment, as specified Equipment:- Digital Manometer Acceptance criteria:- (Schedule-M) 15 Pascal Test procedure:- Air flow should be measured under full operational condition. Pressure diff. should measured between two interconnected diff. class environment. Digital manometer

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Filter Integrity Test:- Objective:- To provide evidence of the integrity of the HEPA filter Acceptance criteria:- 99.97 efficiency- 0.03% particles of 0.3 µm 99.99 efficiency- 0.01% particles of 0.3 µm 26 2.Evaluation of Filter test:-

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DOP ( Dioctyl phthalate) Test

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DOP Test Procedure:- DOP test Light scattering Photometer Aerosol Generator HEPA filter PVC tube Sample before filter Sample after filter DOP Injection

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4. Power-fail and Recovery test:- Objective:- To test the AHU, electric or electronic control system during a power fail and recovery cycle. Test procedure:- Proceed to simulate the failure Bring system to a complete stop Wait the required time before restart to prevent mechanic or electrical damage to the system Restart the system Acceptance criteria- The controlled environment should recover to the original setup after loss of power.

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Test procedure:- Environment is divided by grid Measure by Airflow meter (A) Air flow velocity and uniformity test:- Objective:- To determine the air flow velocity and uniformity of unidirectional air flow. Acceptance criteria:- 2ft×2ft Airflow meter Vertical flows 0.30 m/sec ± 20% Horizontal flows 0.45 m/sec ± 20% 5. Laminar Air flow system:-

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Objective- To verify the parallelism of the airflow throughout the work zone. Test procedure:- (smoke test) 5. Laminar Air flow system:- reference (B) Air flow parallelism test:- Titanium tetrachloride stick

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PERFORMANCE QUALIFICATION Test :- perform in under the dynamic/actual condition. OBJECTIVE :- To verify and document that an HVAC system provides acceptable control under Full Operational conditions. 1. Temperature control test 2. Humidity control test 3. Air cleanliness test 4. Surface bio-burden Test

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Equipment - Thermometer 1.Temperature control test:- Test procedure:- Environment is divided by a grid Size of square- 60cm×60cm or more Sampling location- work height Result compare with specification 60×60cm Objective: - To demonstrate the ability of the HVAC system to control temperature. Acceptance criteria:- Temp. 20±2ºC

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2.Humidity control test:- Acceptance criteria:- Humidity: 45±5% Equipment - Automatic humidity recorder Objective: - To demonstrate the ability of the HVAC system to control humidity. Digital moisture meter 34 Test procedure:- Environment is divided by a grid Size of square- 60cm×60cm or more Sampling location- work height Result compare with specification 60×60cm

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Acceptance criteria:- Critical area- NMT 100 particles of 0.5 µm/ft 3 Other area - NMT 10000/100000 particles of 0.5 µm/ft 3 3.Air cleanliness test:- Objective:- To determine air cleanliness specified in the process functional requirement. Equipment:- Digital P article counter Particle counter 35

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Acceptance Criteria:- Environment CFU Critical 1 Other 5 Controlled 20 Objective :- To determine that complete operational facility can meet the surface bio-burden requirement specified in the process functional requirement. 4.Surface Bio-burden Test:- Test procedure :- Media filling Test Sampling time - 20 min Incubation time-18-24 hr at 35ºC Bacterial colony counter RODAC plates Hycon contact plate Swabs Samplers Method

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APPLICATIONS OF HVAC Health-Care Facilities Residences Educational Facilities Laboratories Pharmaceutical Industries Non Pharmaceutical Industries Retail Facilities Tall Buildings Hotels Places of Assembly Nuclear Facilities Commercial and Public Buildings 37

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CONCLUSION AHU is a Heart of Pharmaceutical Industries that purify the outside air and circulate all over the areas. HVAC system provide specific set of environment condition which required to make quality product so therefore it must be validated. 38 Heart

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REFERENCES Nash R.A., Wachter A.H., Pharmaceutical process validation, 3 rd edition, Marcel Dekker Inc; 217-257 Potdar A.M. 2007, Pharmaceutical Quality Assurance, 2 nd edition , Nirali Prakashan; 8.1,8.70,13.2. http://en.wikipedia.org/wiki/HVAC http://www.hvachome.net

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