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What is Validation?

Testing and verifying the quality, reproducibility and reliability of facility and its design, systems (HVAC/water/pressurized air etc.), equipments, process or product.

It proves that the specific process works and will work steady and continuously in conformity with predefined specification and quality criteria with proof documents having high level of confidence.

Click here to view the validation standards table...

Validation should be repeated when there is a change in the process or conditions, in the composition or size of the product, in the production equipment (an important maintenance) or in raw material.

What are the differences between validation and qualification, verification and calibration?

Qualification: It is a single step of whole validation process which is performed to assure that an equipment or software meets the design or installing or operating or performance specifications by using documented test plans. It is one of the elements of a whole validation plan. It is a process which is applied to represent “unit” tests of individual elements.

Calibration: Measurement which shows the relation between the values read on a measuring equipment/system and the known values of the measured under certain conditions.

Verification: Assessment of the measuring equipment/system that is convenient/appropriate for intended usage especially between two calibrations based on a certain criteria (or a group of criteria).

What is a Protocol?

A protocol is a written plan which composes test parameters, product characteristics, production equipments and acceptance test results, comprises black points and information about how the validation will be performed and related records.

What are the abbreviations related with validation?

URS: User Requirement Specification
FS: Functional Specification
DS: Design Specification
DQ: Design Qualification
IQ: Installation Qualification
OQ: Operational qualification
EQ: Equipment Qualification (IQ and OQ)
PQ: Performance qualification
PV: Process Validation
HVAC: Heating Ventilation Air-Conditioning
LAF: Laminar Air Flow Cabinet
BSC: Biosafety Cabinet
HEPA: High Efficiency Particulate Air
AHU: Air Handling Unit
PAO: Poly-Alpha Olefin
DOP: Dioctyl Phthalate

What is Installation Qualification?

Ensure that the system has been installed in consideration of all key concepts and equipment supplier concepts according to approved design criteria with objective proofs.

What is Operational Qualification?

Ensure that the system works within the predefined design criteria with objective proofs.

What is Design Qualification?

Demonstrate that design requirements and specifications meet the next specification or latest applications and all key concepts with objective proofs.

What is Performance Qualification?

Ensure that the process which meets all predefined criteria is stable with objective proofs under predefined conditions and even under worst conditions.

What is Prospective Validation?

Tests which are performed before application/implementation of a product or system.

What is Prospective Validation?

Tests which are performed before application/implementation of a product or system.

What is Concurrent Validation?

Tests which are performed simultaneously with production.

What is Retrospective Validation?

Validation which is based on only past results of product or system.

Which tests should be performed in hospitals?

According to international standards, only particle count test is not adequate for assessment of ventilation system operating rooms in hospitals.
Other required tests based on TS 11605 EN ISO 14644-1 B.3 are:
    • Airflow Velocity Test
    • Pressure Differential Test
    • Filter Leakage Test

What is air change rate?

Air Change Rate = Total Airflow Volume Of Air Handling Unit (m3/h) / Area Volume (m3)}

What are GMP Good Manufacturing Practices?

They are the rules defined by FDA, which assure production, control and documentation of pharmaceutical products in compliance with quality standards and intended usage and its license or product requirements.

What is a Clean Area/Room?

It is an area/room in which airborne particle concentration is controlled, which is constructed and used to minimize the introduction of particles into the room, generation and retention inside the room and also in which other relevant parameters like temperature, humidity and pressure are controlled as required.

TClick here to view clean area classes table...

May every area/room be certificated?

The clean area/room which meets the following criteria may be certified:
    • Specified Ventilation System (HVAC)
    • Specified Design, Size
    • Specified Construction Material
    • Appropriate Equipment
    • Specified Hygiene Application
    • Specified Circulation
    • Complete Personnel Training

Clean rooms are designed not to generate and host any pollution.
The ceilings and working surfaces are required to be resistant to peeling, smooth surfaced and made of material which does not host dirt and microorganisms, like plastic, stainless steel etc.

Entrance to clean rooms is provided by double door air locks. There must be interlocks or warning systems which prevent both doors open at the same time.

The equipments within the clean room are required not to generate particles while operating.
The contamination of particles and microorganisms and introduction into the clean room must be prevented.

What is as-built clean room?

Clean room in condition where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present.

What is at-rest clean room?

Clean room in condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present.

What is operational clean room?

Clean room in condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon.

What is fumigation?

Biosafety cabinet where infective material is worked should be disinfected with fumigation by customer before validation test. In a biosafety cabinet which is manufactured to prevent leakage, the fumigation can be conducted by heating 25 ml formalin with electrical heater. Fumigation should last for a minimum of 6 hours, preferably during a night. After fumigation, while the bio safety cabinet is being ventilated, no one should be near or in front of the cabinet.

What is HEPA Filter?

It is a dry type filter, which is placed in a rigid frame, has a minimum particle collection efficiency of 99.97% (maximum penetration 0.03 %) of 0.3 µm mass median diameter particle size.

What are filter types?

Filter the table below are given in kind.

Click here to view the filter types table...

What is Emery 3004?

The liquid of poly-alpha olefin (PAO) which is used to determine the leakage in filters during HEPA filter leakage/integrity/DOP test in clean areas and LAF cabinets. It is vaporized with high temperature in aerosol generator. It may be supplied from ATI Air Technologies International Company with the trade name EMERY 3004 PAO-4. I.C.C.E Turkey has been Turkey Sales Distributor of ATI since 1998.

EMERY 3004 catalog, DS (data sheet) and MSDS (material safety data sheet) are given in Services – Equipment Sales and Services Part.

What is nitrogen gas used for?

It is used to create 50 psi (3-3,5 bar) pressure required for pressure regulator of aerosol generator in HEPA Filter leakage test. It is defined in aerosol generator user manual as “compressed inert carrier gas” which is used to prevent fire and explosion risk.

Nitrogen gas may be supplied from supplier like HABAŞ and BOS-Linde Gas in 10 liter tubes.

Click here to view MSDS (material safety data sheet) of nitrogen gas...

What is smoke tube?

It is used to increase particle concentration in the clean room in Decontamination Test and to define the direction of airflow in Airflow Direction Characteristics. When air passes through sulfuric acid in glass smoke tube, a white smoke is generated. The determination of airflow direction is done with the movement of this smoke. The particle concentration in the environment increases by the smoke generated in the clean room.

It may be supplied from supplier like Draeger and MSA.

Click here to view DS (data sheet) of smoke tube.
Click here to view MSDS (material safety data sheet) of smoke tube.

What is Sterilization?

Sterilization was defined as extinction of all microorganisms including bacteria spores since 1995. This definition was changed by AAMI (Association of Advancement of Medical Instrumentation) as elimination/kill of microorganisms in the environment to a degree that acceptable sterility assurance level is maintained. (Sterility Assurance Level-SAL).

SAL can be defined as the 10-6 probability of spores living after sterilization process or the probability of an alive spore in a suspension after the sterilization process is repeated one million times. This modification of definition provided the sterilization process to be measurable, controllable in practice. All kind of materials, equipment, implant and liquid which contact sterile parts of human body are required to be sterile.

What is a Biological Indicator?

Biological indicators are used to evaluate whether the sterilization process provides the targeted biological extinction. In biological indicators there are bacteria spores which are known to be the most resistant bacteria to sterilization. (For vapor and formaldehyde sterilization Bacillus Stearothermophilus, for dry heat and EO-ethylene oxide sterilization Bacillus Subtilis, for cobalt and gamma ray sterilization Basillus Pumilus spores are used.)

For autoclave validation, biological indicator (ampoule and strip) “Bacillus Stearothermophilus ≥106, D value>1 minute” will be provided by customer and will be placed beside validation device for parallel study.

Biological indicator may be supplied from supplier like Merck, 3M and Ravenlabs.
I.C.C.E. İstanbul Validasyon ve Eğitim Ticaret Limited Şirketi
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