SERVICES IN MKP VALIDATION

v VIDEOGRAPHY/SMOKE PATTERN

v VALIDATION OF LAF

v CLEAN ROOM

v TEMPERATURE MAPPING

v FILTER INTEGRITY TEST (DOP/PAO)

v RH MAPPING

v RECOVERY TEST

v PARTICLE COUNT

1.VIDEOGRAPHY/SMOKE PATTERN

        Smoke pattern tests are conducted to confirm the unidirectional airflow exiting high efficiency particulate air i.e. HEPA filters or ultra low particulate air i.e. ULPA filters. This test provides visual evidence of airflow direction which is a useful demonstration and diagnostic of facility performance.

        Smoke pattern today is of prime importance in evaluating clean room performance. This pattern indicates the air flow pattern in a room and is helpful in air flow pattern analysis. The prime function of clean room is also to maintain proper air flow to generate necessary scavenging tool. Videography is a tool which can be used for deriving above important criteria.

2.VALIDATION OF LAF

        Bio-safety Cabinet - A biosafety cabinet (BSC) is an enclosed, ventilated laboratory workspace specially designed for safely working with materials contaminated with (or potentially contaminated with) pathogens, requiring a defined biosafety level. Pathogens are a group of microscopic organisms that are capable of reproducing on their own, causing human disease by direct invasion of body tissues. Bacteria often produce toxins that poison the cells they have invaded.

        The primary purpose of a bio safety cabinet is to protect the laboratory personnel, product and the surrounding environment from pathogens and other biohazards  during routine procedures. These bio safety cabinets are designed to meet diverse applications in the life science, clinical, pharmaceutical and industrial laboratory. All exhaust air is HEPA-filtered as it exits the biosafety cabinet, removing harmful bacteria and viruses.

        Reverse LAF - Reverse Laminar Air Flow Unit operates on a re-circulatory airflow principle providing containment by air movement. The pre-filters located at the base of the rear wall capture the airborne contaminants generated. Intake velocity at pre-filters increases to ensure scavenging effect. A small percentage of air is discharged from the booth through the bleed exhaust HEPA filter to maintain the working space under negative pressure. The advantages of these units are that there is no cross contamination and also no risk or inhalation of powders.

        Dynamic Pass Box - Dynamic Pass Box is designed to allow material transfer through controlled environment without much personnel movement to minimize man /material movement & avoid cross contamination between different classified areas. This is specifically installed to minimize movement of personnel for transfer of material into and from the clean room. Dynamic Pass Box provides a barrier between the areas and sweeps away particulate load if present on the surface of object.

3.CLEAN ROOM

        Cleanroom is a modular environment in which the important parameters such as air flow, differential pressure, relative humidity, temperature, airborne particles and microbes are kept under control.

CLEAN-ROOM VALIDATION IS PERFORMED FOR THE FOLLOWING PURPOSES:

       To ensure that the design of facility meets with its intended purpose; to ensure that the facility, equipment, and environment conforms to the User Requirement Specifications (URS); to ensure that the facility, equipment, and environment comply with the defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system meets with the defined standards.

        Post validation, cleanrooms are certified to a chosen class of ISO 14644-1. Each class of ISO14544-1 has its unique requirements that must be made for a facility to be classified in the specified classification.

4.TEMPERATURE MAPPING

       We perform validation tests for Temperature and Humidity Measurement in two stages. In the first stage, general temperature and humidity uniformity are tested. This stage of test is done to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for occupant comfort.

        The second level is done to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for both the occupant comfort and process temperature control.

5.FILTER INTEGRITY TEST (DOP/PAO)

       We perform detailed HEPA/ULPA filter integrity tests. These tests are mainly performed for the Pharmaceutical and Microelectronics industries. The tests are done in accordance with IES-RP-CC-001-86 & ISO 14644. We have sophisticated equipment to perform HEPA Filter Integrity Test with both DOP (i.e. Di-Octal Phthalate) and PAO (i.e. Poly Alpha Olefin), depending upon client-facility's specific requirements. The above tests assure that client's filters are in conformance with various standards/norms and/or governing agency requirements.

        It is recommended to do the Testing and evaluation of filters minimum once annually and potentiality twice annually for achieving optimum performance. We provide proper documentation and certification which helps to the predict potential performance issues and increases filter life.

6.RH MAPPING

        We perform validation tests for Rh Mapping at two stages. In the first stage, general Rh Mapping uniformity are tested. This stage of test is done to ensure that the clean room's HVAC system maintains the specified levels of Rh Mapping required for occupant comfort. The second level is done to ensure that the clean room's HVAC system maintains the specified levels of Rh Mapping required for both the occupant comfort and process temperature control.

7.RECOVERY TEST

        We execute recovery tests for clients across Industries. These tests demonstrate the ability of the clean room to remove particulate by purging the area with filtered air. It also testifies if the room can change from a "dirty" to "clean" state within the specified time. The test is conducted by experienced technicians from team. Our technicians have enriching experience and provide clients with high quality service.

        The ultimate goal of our company is to assure complete satisfaction of clients through effective execution of services and by providing best array of clean room equipment. We ensure that client's clean room facility is performing properly and accurately.

8. PARTICLE COUNT

        The Particle Count Test done by us provides complete airborne particle count cleanliness classification. This test determines the actual particle count level within the facility at the time of the test. The test determines particle count on basis of As-Built, At-Rest, or  Operational as per ISO 14644 . The desired particle size(s) , the room occupancy state and the room classification shall be known prior to the beginning of the tests and shall be as specified in the URS documents.

Significance of validation in pharma companies- Guide to a vital prospect of the pharmaceutical Manufacturing Life cycle.

                         The procedure of qualification and validation is applicable to any prospect of operation that may affect the quality of the product. The elemental goal of the validation process in the pharmaceutical industry is to have documented cogent evidence that quality is part of each and every step of the manufacturing and distribution system, rather than simply testing products at the end of the process.

                          The Food and Drug Administration (FDA) has fixed testimonials for all stages of the manufacturing procedure life cycle, whether referred to as plant equipment, software or risk management. Moreover, the FDA has the authority and duty to scrutinize and evaluate the validation process executed by manufacturers.Whether it is due to government rule, cost effectiveness or quality assurance, the pharmaceutical industry cannot neglect the requirement of a proper validation process.

MORE ABOUT VALIDATION.

                          The term validation in the context of pharmaceutical manufacturing can well be misinterpreted and because of that, companies must specify what it means for them and point how exactly they will carry it out in order to achieve the craved results. A defined validation methodology is critical in deciding the range of validation required.  The Validation Plan should define the risk based coming taken to balance business requirements, operational and procedural controls while meeting regulatory necessities. It is significant to have proven techniques to find cost efficiency associated with applying and conserving computer systems in regulated environments.

                          Frequently, companies incline to either overdo or under-do it. Deficiency of knowledge about how and what to validate can translate into too much documentation because of doubtfulness as to where to draw the line or not enough information because the validation task seems so intimidating.The example includes: from an examining standpoint, if an area prefers to report information over and above what is accepted in the requirements, their system providers, whether in-house or third party, need to be mindful to adjust their testing systems accordingly. Otherwise, that rawness could be misinterpreted as a deficiency.  An example of under-doing includes the lack of recovering from the requirements through the executed test protocols.Additionally, many companies mistakenly trust that the term “validation” is exclusively IT-area, when in fact the concept of validation involves a number of aspects beyond computer system validation, including, but not defined to: the input, the outputs, the users, equipment, facilities, cleaning, process, and analytic method.Process validation is the accumulation and evaluation of data, from the process design stage through the end of the product life cycle. This ongoing compilation of data provides the basis for establishing scientific evidence which resolves that a process is capable of consistently delivering quality product.

The Importance of Validation in Pharmaceutics

             The Federal Food, Drug and Cosmetics Act Section 501 (a) (2) (B) which says that “a drug is deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or were not operated or administered in conformity with Current Good Manufacturing Practices, "answers as the legal basis for the practice of validating.

In today’s world of withdraws and lawsuits, Pharmaceutical manufacturers originate a Validation Master Plan and thoroughly document how the validation process is posted.

As more pharmaceutical companies find themselves outsourcing a kind of customer-facing services to third-party traffickers, the role of a contact center is an important one during the life of a product, as interactions with consumers and medical professionals become essential for traversing. In an environment where consumer refuge and privacy are important, a cautiously documented system and process leaves no room for interrogations during an audit, internal or external investigation or government-mandated recalls.

MKP  - A PERFECT SOLUTION FOR VALIDATION

EXPERIENCED PROFESSIONALS

MKP Validation have a panel of Experienced Professionals who will Validate your products and achieve quality results.

QUALITY SERVICES

They adapt highest quality levels conforming to today's world of regulations.

INSTANT RESULTS

Achieve your goals by getting instant results on validating your products/facility with MKP VALIDATION.

GROW YOUR BUSINESS

Enhance your business by providing quality products to customers after validating with MKP VALIDATION.

CERTIFICATION

Equipment’s used also fall under National Accreditation Board for Testing and Calibration Laboratories  Certification(wherever need).

CONTACT

MKP VALIDATION
Plot No. A-791/10,
Village Khairane,
T.T.C. Ind. Area,
Navi Mumbai - 400710.
Mob: 9819144854/ 9820198529
hardik@mkprecision.in
golani@mkprecision.in

AN INTRO TO CLEAN ROOM VALIDATION , M K P- AN ART VALIDATION HOUSE

CLEAN ROOM VALIDATION

                                                                  Clean-room is a modular environment in which the important parameters such as air flow, differential pressure, relative humidity, temperature, airborne particles and microbes are kept under control. The aim of Cleaning Validation is to launch cleaning procedures & residue limits that are practical, achievable, and verifiable and insure safety. Clean rooms must be validated prior to performance. This process ensures that the clean room is functioning right. The standards that must be measured in order to validate a clean room let in: the intensity and quality of air supplied, air drift between the clean room and other rooms, air motion within the clean room and the particle counts in the clean room, including microbiological if requisite. Specific standards specify the necessities for clean room validation.

After a clean room is validated and becomes active it must regularly be checked to ensure that it extends to meet initial measures. Particular standards list the time intervals at which clean rooms should be examined and the minimum requirements a clean room must meet. These standards admit ISO 14644-2. The testing outlined in the standard ensures that the product manufactured in the room will be suit for its intended function.

CLEAN ROOM VALIDATION IS PERFORMED FOR THE FOLLOWING PURPOSES:

To ensure that the design of facility meets with its intended purpose; to ensure that the facility, equipment, and environment conforms to the User Requirement Specifications ( URS ) ; to ensure that the facility, equipment, and environment comply with the defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system meets with the defined standards.  

Post validation, clean-rooms are certified to a chosen class of ISO 14644-1. Each class of ISO14544-1 has its unique requirements that must be made for a facility to be classified in the specified classification.

Precepts of Clean Room Validation/ Testing

Certain principles are used to head the validation and maintenance of clean rooms:

-Air movement in the clean room should be sufficient to guarantee that no areas within the room collect high concentrations of contamination.

-The air supply to the clean room is prime and will not add significantly to the contamination in the room.

-The air supplied to the clean room is of sufficient quantity to debase or remove contamination generated in the room.

-The air in the clean room travels from clean to less-clean areas. This downplays the unsuitable movement of contaminated air. This movement is particularly significant in relation to doorways and construction fabrics.

Clean Room Tests

There are certain tests that should be performed regularly to find out the effectiveness of the clean room. These tests include:

-Air Supply and Extract measures

For turbulently ventilated rooms, the air supply volumes should be calculated. Selection volumes should also be measured periodically. For unidirectional airflow rooms the air velocity should be evaluated.

-Pressure Differential among Areas

It is significant to confirm that all airflow in the clean room happens in the desired direction (from more clean to less clean). Measuring pressure difference between two designated areas , permits airflow direction to be determined.

-Filter Installation Leak Test

The High Efficiency Particulate Air (HEPA) filter and its housing must be determined sporadically to ensure no airborne contamination can by-pass the filter installation and enter the clean room.

-Containment Leak Test

Testing is essential to substantiate that no airborne contamination enters the clean room from neighboring higher pressure areas through leaks in the construction testing.

-Air motion Control and Recovery

The character of air movement control test needed is learned by the ventilation system in the room. Turbulently ventilated rooms need to be checked to ensure that there are no areas within the room with deficient airflow. Unidirectional airflow rooms should be determined to ensure the air velocity and direction is correct, particularly within the vital area where products are displayed to contamination.

It may also be essential to test the 'retrieval' of conventionally ventilated clean rooms from test particles or from naturally occurring particles that are introduced into the room.

-Airborne molecule and Microbial Concentrations

Once these tests have been passed the room will be evaluated for airborne particle concentration levels and, whether applicable, microbiological to insure that these levels follow with design

M K Precision has set up a state of the art validation house providing complete range of solution necessary for Validation of Pharma clean rooms, operation theaters, Labs, Electronic Industries.

M K Precision has laid a platform that will encourage customers to have single point of contact for all their needs/ requirements. This is one of the stepping stone that M K precision has taken very seriously.

With daily up-gradations and continuous revisions in the clean room requirement, validation today has become an imperative service for any industry dealing with critical products.

M K Precision has taken a professional approach in catering these market needs.

Qualification and Validation services by MKP

MKP Validation

MKP Validation is basically a customer-centric company in the field of turnkey solutions/validation services through top class value engineered products & services. MKP Validation has set up a state of the art validation house providing an all-over range of solution essential for Validation of Pharma clean rooms, operation theatres, Labs, Electronic Industries.

MKP Validation has laid a platform that will promote customers to have a single point of contact for all their requirements. With day-to-day upgradations and continuous revisions in the clean room requirement, validation today has become an imperative service for any industry handling with critical products. MKP Validation has taken a mastery approach in providing these market needs.

The Company regards to pursuing the goal of collective excellence through personal and collaborative attempts to raise health, safety and welfare by providing economical, responsive and effective professional engineering services using top-notch & futuristic validation equipment’s meeting global touchstones.

MKP Validation team consist :

- Engineers with supreme qualification & necessary training.

- Professionals with admirable experience & a proven track record, with dedicated approach - thus giving correct direction to the customer.

- Documentation Experts who process the documents with due diligence and to the highest standards of compliances.

They are offering the services like:

[1]   Clean Room

[2]   Validation Of LAF

[3]   Videography/Smoke Pattern

[4]   Temperature Mapping

[5]   Filter Integrity Test (DOP/PAO)

[6]   RH Mapping

[7]   Recovery Test

[8]   Particle Count

Properties of MKP Validation :

- EXPERIENCED PROFESSIONALS

MKP has a panel of Experienced Professionals who will Validate your products and achieve quality results.

- QUALITY SERVICES

Adapt highest quality levels conforming to today's world of regulations.

- INSTANT RESULTS

Achieve your goals by getting instant results on validating your products/facility with MKP VALIDATION.

- GROW YOUR BUSINESS

Enhance your business by providing quality products to customers after validating with MKP VALIDATION.

- CERTIFICATION

Equipment’s used also fall under the National Accreditation Board for Testing and Calibration Laboratories (NABL) Certification (wherever applicable). 

          If you have any validation requirement don't hesitate to visit - www.mkpvalidation.com