Friday, September 1, 2017

Smoke Pattern Test at MKP Validation House


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.

 We ensure that client's clean room facility is performing properly and accurately. For more details please be free to contact - www.mkpvalidation.com

Sunday, August 20, 2017

Particle Count Test for Cean Room

Particle Count Test for Clean Room



The Particle Count Test done by MK Precision 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. 


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

Friday, August 4, 2017

Recovery Test Service

Recovery Test - 1



We execute recovery tests for clients across many type of 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 a team of experienced technicians. We provide to our clients the highest  quality of service.

Recovery Test - 2


        The ultimate goal of our company is to ensure complete satisfaction of clients through effective execution of services and providing best array of clean room equipment. We ensure that client's clean room facility is performing properly and accurately. For more details please be free to contact - www.mkpvalidation.com

Wednesday, July 12, 2017

Temperature Mapping Services Guide


What is Temperature Mapping?

         Many industrial, laboratory and manufacturing processes deal with products that are temperature-sensitive, like foods, pharmaceuticals etc. Maintaining prescribed temperature all around the controlled space is a vital aspect for these processes. Measuring and mapping temperature at different points of the controlled space and maintaining them within a range adhering to thermal compliance norms is essential.
         Apart from work-environments, temperature mapping is useful for ensuring temperature-controlled storage systems like cold storage units, warehouses, refrigerators and the like. This calls for cooling the entire space effectively.

Definition of Temperature Mapping :

           Temperature mapping is the process of mapping the frequency of temperature fluctuations, differences and the range of temperature within a controlled space, over a period of time. It can locate areas where the maximum temperature fluctuations occur and analyze the source of the variations.

Reasons for Temperature change and need for Mapping :

           In a temperature-controlled environment, the temperature at different points can vary by up to 10°C. Typically, the central area maintains a nearly constant temperature, while areas surrounding the cooling fans, access points and the edges tend to fluctuate a lot. Another factor that influences the internal temperature is seasonal changes of weather, especially in a warehouse. Therefore, Temperature Mapping is a critical input to the the above process.

Temperature in a particular space can be affected by a number of factors, which include:

  •  Proximity to doors that are frequently opened
  •  Distance from cooling fans
  •  Air circulation within the space
  •  The quantity of products stored in the area
  •  Body heat from personnel working in the space
  •  Heat radiating from machinery and devices, and more

Purpose and Importance of Temperature Mapping :

         The purpose of temperature mapping is to ascertain the variation of temperature, not just within a controlled system as a whole, but at different points within the enclosed space. A fluctuation of even a few degrees can have severe consequences for processes where temperature-control qualification is a critical aspect of maintaining quality.

Some of these processes include:

   · Fresh and treated foods
   · Medication
   · Vaccines
   · Dairy products
   · Meat products

These products, and the systems they are processed within the controlled space, require a strict control over the refrigeration and air-conditioning systems, to make sure the temperature is maintained within an acceptable range to prevent spoilage or contamination.

What are Temperature Mapping Services and Why are they Required?

            Regulatory authorities like the FDA and Health Canada have increased the pressure on drug and pharmaceuticals manufacturers to comply with GMP (Good Manufacturing Process) guidelines and requirements for temperature-controlled storage. Compounded by the elimination of financial risks related to equipment failure, they have become a vital part of consumer safety as well as losses associated with product quality or associated failures within storage and logistics operations.
           Todays pharmaceutical manufacturing and SCM (Supply Chain Management) organizations have a greater responsibility than ever before. They need to have a clear understanding of the processes that could impact product quality or consumer safety, as well as every aspect of the procedure involved.
           Creating a temperature profile of critical storage equipment or locations is essential, and a critical part of managing risks related to product quality and increasing consumer safety. To balance the returns on your investment, you may have to balance these elements combined with the costs of packaging and your environmental monitoring programs, against your staffing requirements.


Wednesday, June 28, 2017

RH Mapping Services by MKP Validation


                                 


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.




Saturday, February 25, 2017

Clean Room Validation Services


A 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.
CLEANROOM VALIDATION IS PERFORMED FOR THE FOLLOWING PURPOSES:

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

Monday, January 30, 2017

Rules for Clean Rooms

Rules to be followed in the Cleanrooms :


Within a clean room, many rules-of-conduct must be followed to ensure that products are not contaminated. The management must produce a set of written procedures suitable for their room. It may be useful to have these 'does and don'ts' posted in the change or production area. Commonly used procedures that may be adopted are given below. These procedures do not consider the choice of cleanroom garments, masks, gloves and similar clothing items.

Air Transfers within the Cleanrooms To ensure that air is not transferred from an area of high contamination to one of lower contamination (e.g. the outside corridor to the production room) the following disciplines should be adhered to:

1. Personnel must always come in and out of the cleanroom through change areas. The change area is used not only to change clothing but as a buffer zone between the outer dirty corridor and the inner clean production area. Personnel should not use any entrance, such as an emergency exit, which leads directly from the production area to the corridor; this will allow contamination to enter directly into the cleanroom, and their garments may also become contaminated.

2. Doors should not be left open. If they are, air will be transferred between the two adjoining areas because of general air turbulence as well as air transfer caused by a temperature difference between the two areas.

3. Doors should not be opened or closed quickly, or air will be pumped from one area to the other.

4. Doors usually open inwards into the production room and are held shut by the higher pressure. However, to aid the movement of personnel who are carrying materials, some doors open outwards. Doors should then be fitted with door-closing devices to ensure that the doors are kept closed, and shut slowly to reduce the air transfer. Doors without handles will assist in preventing contamination of gloves.

5.When passing through the doors in an airlock, personnel should ensure the first door is closed before going through the Next one. Electrical interlocks between entry and exit doors achieve this, but care must be taken to ensure that there is no danger in the case of fire. Indicator lights, which show if the doors are shut, are also used. Pass-through hatches should be used in a similar way.


CONTACT : 

 MK precision metal parts pvt ltd
 Address :Plot No. A 791/10,
 Village Khairne, TTC. Industrial Area,Navi Mumbai,
 Maharashtra 400 710, India.
 Phone : +91-22- 41021700-50 (51 Lines)
 Mobile: 9820198529 / 9819144854
 Fax:+91-22-27782521/41021777
 Email: sales@mkprecision.in