Validation & Qualification
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Validation provides documented evidence, to a high degree of assurance, that the computerized systems are accurately and reliably installed and can perform their functions as intended for use. Medical device validation refers to the process of confirming a medical item, program, or software works in the way in which it was intended. Validation is essential to ensure each device is safe for use and will work correctly for all patients with no room for error or harm.

SOFTWARE VALIDATION

Software Validation Purpose

The purpose of Software Validation is not to prove that the software can only do what you want; and identifying and mitigating issues that may adversely affect the production of regulated products and ingredients.

How is Software Validation Performed?

Software Validation is done in 4 stages. These;

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

If we briefly explain the implementation or implementation of Software Validation, a Validation Plan is first made. In this plan, the documents and explanations of the software system, the environment in which it will be installed, who will be in the validation team and their responsibilities are determined.

Then the system requirements are determined. At this stage, the necessary conditions for the software to work in line with your expectations should be outlined.

In the next step, the Validation Protocol and test specifications are created. At this stage, the requirements that the software is expected to meet and the proof that the software is working properly are summarized and test plans are created.

In the final stage, the tests are carried out and documented. All data such as positive results of tests, errors and failures encountered should be documented at this stage.

What Does Software Validation Do?

Software Validation;

  • For a continuously improving product and system quality, 

  • In order to meet the compliance with the legislation, 

  • In order to increase the possibility of completing the projects on time and within the determined budget limits, 

  • In order for the management to clearly understand the current risks and take the necessary actions correctly, 

  • In order to reduce costs by early detection of defects in pre-production processes, 

Software Validation Standards

Some of the software validation standards are;

  • EN ISO 13485:2016

  • IEC 62304:2006+AMD1:2015

  • IEC/TR 80002-1:2009

  • ISO TR 80002-2:2017

  • IEC TR 80002-3:2014

  • IEC 82304-1:2016

  • FDA 21 CFR Part 11

  • GMP

EXCOPAN supports its customers in the validation process of systems/software, in compliance with the relevant authorities, with the CONVAL group, an industry leader specialized in validation services and software testing in line with regulatory requirements.

PROSES VALIDATION

Process Validation is a formal methodology that companies utilize to manufacture products with a defined process, leading to products that consistently meet their specifications and quality requirements

The scale-up procedure for a medical device product is done using Design Control and Design Reviews at various points to evaluate the design requirements. This helps ensure the product is on the right track to meet its specifications. Design Controls require documentation that details device verification for safety and efficacy. It should include the user requirements specification, design and development planning, risk assessment, and design verification.

EXCOPAN, in partnership with the CONVAL Group, provides its customers with validated production processes, all elements of which are in compliance with the regulations, in order to minimize business risk and increase market competition.

EQUIPMENT VALIDATION

Equipment qualification is a necessary and critical step in ensuring that a product or service is provided accurately and consistently with requirements aligned with medical device manufacturing and testing. This is especially critical for the medical device industry because the medical device manufactured by a company is considered a piece of equipment and requires qualification, as much as other equipment and instruments involved in manufacturing. Verifying prerequisites before qualification ensures a safe and smooth qualification process. A prerequisite in an equipment qualification is a documented verification intended to demonstrate that everything is in order prior to initiating the execution of the qualification section.

For medical device companies, using prerequisites translates into less time and n de spent on avoidable delays. Because the requirements for a piece of equipment or a device can vary widely from company to company n deven between pieces of the same type of equipment, it is important to devise a universal set of prerequisites that will address all potential trouble areas.

Prerequisites in an Equipment Qualification Protocol

Setting up equipment in a medical device manufacturing facility includes ensuring that the equipment will safely and consistently work as intended. To do this, it is necessary to verify the following actions:

  • That the equipment is installed according to the manufacturer's instructions.

  • That the equipment is operated properly and consistently.

  • That the equipment performs within the requirements determined by the facility.

To cover all of the necessary criteria, equipment qualifications are typically organized by separating the protocol into three sections: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).

EXCOPAN, in partnership with the CONVAL Group, provides support both in meeting all the qualification requirements of your existing and/or new equipment as well as in the design, design review, selection and installation of new equipment.

TRANSPORT VALIDATION

Transport validations are performed to examine the suitability of packaging compatibility and safety.  The transportation and the storage must not affect the properties of medical device ie, the device must be damage free, maintain sterility no physical damage, no biological contamination and function as intended. In the transport validation test, the medical device package undergoes several simulated environmental conditions to check whether the device withstands without any damage to its properties.

The new EU MDR requirements are listed below:

MDR annex I general safety and performance requirements (GSPR), specifies the transportation and storage requirements of medical devices. The requirements can be summarised as;

  • Device shall package in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage.

  • Device having a specific microbial state shall be packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions

  • The package shall ensure that retain the sterile condition, till the pack is broken.

What Does Transport Validation Include?

Input data for the design of the transport validation project plan includes product label claims, existing stability data, and existing processes and systems. Where such data is not (yet) available, the validation project plan supports bracketing the required data.

Simulating transport lanes at lab scale can significantly reduce real-life testing.

Basic drop testing, vibration testing, shock impact testing, and accelerated environmental testing with UV radiation and temperature cycles under different humidity regimes can simulate real conditions as closely as possible. Results from these lab tests provide input to design and real-world proficiency testing.

Transport Validation Stages / Taşıma Validasyonu Aşamaları

The design phase of the transport validation project plan encompasses three elements: content, access and vehicles.

Content

Content refers to the type of product transported, i.e. bulk product, intermediate, unlabeled finished product, labeled finished product. 

What is the exposure in transit for the content covered by the plan? Consider not only the way it is packaged, but also the bulk packaging (box packing, shippers, pallet load), both primarily (in contact with the product) and secondary. 

Elements that need to be assessed and evaluated with the risk profile for transport are contact, vibration, temperature, humidity, transport and other possible criteria.

Access

Access covers the furthest distance the product will be transported. Will it be country (local), regional (EU, US, Asia) or worldwide and includes single or multiple transport routes? 

For access covered in the plan, consider the most severe exposures, distance, cycles, and environmental conditions during transport and handover, including expected temperature ranges, relative humidity, out-of-cooling time (TOR), vibration, extended staging, dwell time.

Don't think of it as a pointer for testing, take it as a variable and let the Migration validation project plan result feed back the required range that the stability test should cover. It may not be yet known what minimum or maximum temperatures the product can be exposed to. However, knowing where the product came from and the furthest distance it has to travel will give you an idea of the lowest or highest temperatures the package can be exposed to.

The purpose of transport validation is to provide valuable data about the product being unaffected by environmental conditions and the expected performance of the packaging during transport.

Vehicles

Vehicles encompass modes of transport that can differ, such as by road, by car or by truck and train, by sea and by air.

In general, a combination of road, sea and air may need to be considered. For vehicles in the plan, consider the toughest vehicles or combination of vehicles, quality of roads, vehicles, handovers and more.

Vehicles or a large number of vehicles have a direct impact on the transport packaging, which is necessary to avoid a negative impact on the protected product. For example, rough handling, substandard trucks, or exposure to extreme temperatures are just some of the methods to consider when testing packaging and packaged product.

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in transportation validation requirements and regulation requirements.

1.5.5 TEMPERATURE AND HUMIDITY MAPPING STUDIES IN CONTROLLED ENVIRONMENTS (MAPPING)

It is a study that covers temperature and humidity mapping studies with datalogger devices, realizing worst case scenarios and documenting qualification studies in warehouses, cold rooms, stability rooms, ovens, stability cabinets, refrigerators, water baths and other controlled environments.

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

CLEANING PROCESS VALIDATION

It is very costly to create separate equipment or equipment tracks for each of our same form products with different contents. Therefore, the production of different products is carried out on the same equipment. Is it possible to eliminate the risk of cross contamination with the cleaning processes created in the existing equipment? GMP regulations require validation of the suitability of cleaning processes used in cleaning operations.

In cases where different products are produced using similar equipment, the validation of the effectiveness of cleaning processes established for the equipment is called cleaning validation.

The service content of the cleaning process validation study is as follows;

  • Establishment of cleaning processes and selection of cleaning agents,

  • Preparation of master plans and determination of validation approach,

  • Determination of cleaning validation equipment, qualification compliance checks,

  • Establishment of validation procedures,

  • Worst-case product selection,

  • Selection of sampling points with risk assessment approach,

  • Calculation and formulation of acceptance criteria,

  • Documentation and reporting activities,

The reports of all the above-mentioned studies are prepared in Turkish-English.

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

COMPRESSED AIR/GAS QUALIFICATION

It is a study carried out to control and classify compressed air and/or gases especially used in cleanrooms.

The following services are provided for compressed air qualification work;

  • Carbon Dioxide, Carbon Monoxide Test in Compressed Air

  • Humidity Test in Compressed Air

  • Oil Test in Compressed Air

  • Live Microorganism Test in Compressed Air

  • Inanimate Particle Test in Compressed Air

The reports of all the above-mentioned studies are prepared in Turkish-English.

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

Çeker Ocak Validasyonu

Whether the fume hoods work effectively and their compliance with standard criteria is confirmed by state-of-the-art devices.

The following services are provided for the fume cupboard validation study;

  • Alarm functions test,

  • Air velocity test,

  • Pressure drop test,

  • Visualization test of the weather characteristic,

  • Exhaust air volume test,

The reports of all the above-mentioned studies are prepared in Turkish-English.

Standards Used:

MD 15128           Laboratory Fume Hoods

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

BIOSAFETY CABINET VALIDATION

The efficient operation of the biosafety cabinets and their compliance with the standard criteria are confirmed by state-of-the-art devices.

The following services are provided for biosafety cabinet validation work;

  • Air flow rate test,

  • Filter equipment leak test,

  • Particle count,

  • Air flow direction visualization test,

  • Alarm functions test,

  • Biosafety/Microbiological safety cabinets performance classification and verification

The reports of all the above-mentioned studies are prepared in Turkish-English.

Standards Used:

NSF / ANSI 49 BSC Design, Construction, Performance And Field Certification

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

CLEAN ROOM VALIDATION

The tests required by the standards are carried out with state-of-the-art devices within the scope of performance characterization studies of all cleanrooms, clean areas, operating rooms, intensive care units, and TPN filling rooms.

The following services are provided for cleanroom validation work;

  • Measurement of air flow, air flow rate, number of air changes and air uniformity,

  • Measurement of pressure differences between spaces,

  • HEPA and ULPA filter equipment leak test,

  • Particle counting and classification,

  • Temperature and humidity measurement,

  • Air flow visuality test,

  • Decontamination/recovery test,

  • Measuring the sound level,

  • Biocontamination tests,

The reports of all the above-mentioned studies are prepared in Turkish-English.

Standards Used:

IEST-RP-CC006.3: 2004 Testing Cleanrooms

IEST-RP-CC034.3: 2009 Hepa and Ulpa Filter Leak Test

VDI 2083-Part 3: 2005 Cleanroom Technology Metrology and Test Methods

Eudralex Volume 4: 2008 Medicinal Product for Human and Veterinary Use Annex 1

FDA c GMP: 2004 Sterile Drug Products Produced by Aseptic Processing

DIN 1946-4: 2008 Ventilation and Conditioning-Part 4: VAC Systems in buildings and rooms used in the health care sector

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

DEPIROGENIZATION TUNNEL VALIDATION

OQ and PQ studies of depyrogenization and sterilization tunnels are carried out. If required for depyrogenization, we have services for endotoxin supply and analysis.

The following steps are followed for the stability validation study;

  • Preparation of the validation protocol, which includes the details and objectives of the work to be done,

  • Pre- and post-process verification of reference thermocouples,

  • Empty working temperature distribution test,

  • Loaded heat penetration test,

  • Preparation of the validation report, which explains the whole process with its results.

The reports of all the above-mentioned studies are prepared in Turkish-English.

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

STABILITY VALIDATION

It is the study that covers the package performance and product sterility analyzes after the shelf life tests of medical devices, transportation and representative studies for dropping.

The following steps are followed for the stability validation study;

  • Subjecting the products to the accelerated aging test within the specified period,

  • Sterility analysis on the aged product, application of the package performance test on the aged package,

  • Sending the product to the furthest point in the market by cargo and taking it back,

  • Sterility analysis of the product adapted for transportation, application of the package performance test to the package,

  • Performing the drop test of the product as described in the standards,

  • Sterility analysis of the drop tested product, application of the package performance test to the package,

  • Preparing the validation report, which explains the whole process with its results.

The reports of all the above-mentioned studies are prepared in Turkish-English.

NOTE: It is recommended that sterilization validation and packaging validation be completed in order to carry out the relevant study in a healthy way.

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

AUTOCLAVE VALIDATION

Regardless of the sterilization method used, its validity must be demonstrated and recorded.

Autoclaves are validated according to EN 13060 and EN 285 standards. The samples collected after the studies to be carried out in your facility are analyzed in AYA laboratories and all results are reported.

The following steps are followed for the autoclave validation study;

  • Preparation of the validation protocol, which includes the details and objectives of the work to be done,

  • Performing device probe verification (optional),

  • Performing the vacuum test (Bowie-Dick),

  • Performing repetitive cycles for heat penetration (empty/full),

  • Recording the results with a number of independent dataloggers in accordance with the standards during these cycles,

  • Preparing the validation report, which explains the whole process with its results.

The reports of all the above-mentioned studies are prepared in Turkish-English.

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

STEAM STERILIZATION VALIDATION

Regardless of the sterilization method used, its validity must be demonstrated and recorded.

This study is carried out as a proof of successful sterilization of products that are put on the market as sterile or that are sterilized before use after being put on the market as non-sterile.

The following steps are followed for the steam sterilization validation study;

  • Preparation of the validation protocol, which includes the details and objectives of the work to be done,

  • Determination of product bioburden (bioburden) before starting work,

  • Performing the sterilization process with the same parameters in 3 different cycles in order to demonstrate reproducibility,

  • Performing sterility analyzes of biological indicators placed in the cabinet and the product during the cycles,

  • Performing sterility analysis on products that represent difficult conditions after the cycles,

  • Preparing the validation report, which explains the whole process with its results.

The reports of all the above-mentioned studies are prepared in Turkish-English.

Standards Used:

TS EN ISO 17665-1- Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

PACKAGING VALIDATION

The packaging materials used and the packaging machine are expected to protect your products effectively throughout their shelf life. This process is validated using the ISO 11607 standard. You can get this service for your products that you will provide packaging service from us, as well as for your own device. Samples collected with different parameters in your device are analyzed in AYA laboratories and all results are reported.

The following steps are followed for the packaging validation study;

  • Preparation of the validation protocol, which includes the details and objectives of the work to be done,

  • Determination of critical process parameters and taking samples accordingly,

  • Determination of optimum conditions as a result of critical process parameter study,

  • Process controls (pre-sterilization, post-sterilization, consecutive double sterilization) with the determined optimum conditions,

  • Preparing the validation report, which explains the whole process with its results.

The reports of all the above-mentioned studies are prepared in Turkish-English.

Standards Used:

TS EN ISO 11607-2- Packaging for terminally sterilized medical devices – Part 2:Validation requirements for forming, sealing and assembly processes

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

GAMMA DOSAGE DETERMINATION AND DOSAGE CONTROL STUDY

Regardless of the sterilization method used, its validity must be demonstrated and recorded.

The process of sterilization with gamma rays is validated using the ISO 11137 standard. We provide validation services for "Method 1", "VdMax 15" and "Vdmax 25" methods.

The following steps are followed for the gamma sterilization validation study;

  • Preparation of the validation protocol, which includes the details and objectives of the work to be done,

  • Performing the number of bioburden analyzes specified in the standard to determine the amount of confirmation dose,

  • Performing the dose verification study at the irradiation facility,

  • Performing sterility analysis of the irradiated products in the number specified in the standard,

  • Preparing the validation report, which explains the whole process with its results.

The reports of all the above-mentioned studies are prepared in Turkish-English.

NOTE: It is recommended to complete the packaging validation in order to carry out the relevant study in a healthy way.

Standards Used:

TS EN ISO 11137-2-  Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.

ETHYLENE OXIDE STERILIZATION VALIDATION

Regardless of the sterilization method used, its validity must be demonstrated and recorded.

The ethylene oxide sterilization process is validated using the ISO 11135 standard. You can get this service for your products that you will provide sterilization service from us, as well as for your own device. The samples collected after the studies to be carried out in your facility are analyzed in AYA laboratories and all results are reported.

The following steps are followed for the ethylene oxide sterilization validation study;

  • Preparation of the validation protocol, which includes the details and objectives of the work to be done,

  • Determination of product bioburden (bioburden) before starting work,

  • Performing 1 partial, 3 half, 2 consecutive full cycles with load,

  • During these cycles, monitoring the temperature-humidity with a number of independent dataloggers in accordance with the standards and recording the results,

  • Performing sterility analyzes of biological indicators placed in the device with the products during the cycles,

  • Performing sterility analysis on products that represent difficult conditions after half cycles,

  • Performing package performance and residue analyzes after 2 consecutive full cycles,

  • Preparing the validation report, which explains the whole process with its results.

The reports of all the above-mentioned studies are prepared in Turkish-English.

NOTE: It is recommended to complete the packaging validation in order to carry out the relevant study in a healthy way.

Standards Used:

TS EN ISO 11135-Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices

EXCOPAN serves its customers in compliance with the relevant authorities with AYA Lab, which specializes in this validation requirements and regulation requirements.