POST DATE

12/23/2020 12:16:25 PM POST BY: Admin

Why HVAC (Heating, Ventilation, & Air Conditioning) is an important statutory requirement in Pharma or medical device Industry?

Every Pharma Company in order to establish its commitment towards the production of quality drug must have a designated, well maintained HVAC facility in manufacturing area. The Drugs & Cosmetic Act 1940 and Rules 1945 also require the pharma companies to have well designed and installed HVAC in manufacturing, filling & packaging area to control temperature, humidity, air flow and contamination.

A set Temperature is required to control as effective blending of ingredients in drug manufacturing process may got affected by change in temperature. Also the working of equipments and machinery generates lot of heat which is to be controlled for providing good working conditions. Bacteria, Fungi, virus and other pathogens grows rapidly in warm and humid environment and thus controlled temperature and humidity is must for production in pharma companies.

In order to avoid any contamination, installation of filters along with required air flow is mandatory. Filters control the number and size of air particles present in a closed area within the accepted level of quality standards.

As a matter of fact certain areas require a separate independent Air handling unit from adjacent areas to ensure the above parameters can be established and any cross contamination can be avoided.

Why regular HVAC/clean room Validation is important statutory requirement in Pharma or medical device Industry?

 

Only putting in a HVAC system isn't always completely effective until a regular validation has been carried out to confirm that the installed system is running as per the set parameters and design. Validation means checking, verifying, or confirming the accuracy of a process or system or facility. After performing validation a documented evidence of the findings in form of reports are kept for record which are very important at the time of Audits. Validation reports helps the quality teams to ensure the consistency of established processes/ systems.

The results of validation also helps the maintenance team to take preventive measure on time before the breakdown of the system along with planning the annual maintenance program of the system. HVAC Validation facilitates to find out the deviations incurred in the system and the design during the process over the time. Validation also reduces the risk of non-compliances with regulatory standards. The production capacity of manufacturing units can be optimised by reducing the chances of rejection on account of bad quality.  

It is important here to mention that regular validation of HVAC/ clean room is a mandatory requirement under various regulation viz. FDA (food & Drug Administration), Schedule M of Drugs & Cosmetic Act 1940 and Rules 1945, MHRA (Medicines and Healthcare products Regulatory Agency of UK) and ISO.

 

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POST DATE

12/14/2020 1:17:22 PM POST BY: Admin

HVAC (Heating, Ventilation, & Air Conditioning) important statutory requirement in Pharma or medical device Industry

Why HVAC (Heating, Ventilation, & Air Conditioning) is an important statutory requirement in Pharma or medical device Industry?

 

Every Pharma Company in order to establish its commitment towards the production of quality drug must have a designated, well maintained HVAC facility in manufacturing area. The Drugs & Cosmetic Act 1940 and Rules 1945 also require the pharma companies to have well designed and installed HVAC in manufacturing, filling & packaging area to control temperature, humidity, air flow and contamination.

A set Temperature is required to control as effective blending of ingredients in drug manufacturing process may got affected by change in temperature. Also the working of equipments and machinery generates lot of heat which is to be controlled for providing good working conditions. Bacteria, Fungi, virus and other pathogens grows rapidly in warm and humid environment and thus controlled temperature and humidity is must for production in pharma companies.

In order to avoid any contamination, installation of filters along with required air flow is mandatory. Filters control the number and size of air particles present in a closed area within the accepted level of quality standards.

As a matter of fact certain areas require a separate independent Air handling unit from adjacent areas to ensure the above parameters can be established and any cross contamination can be avoided.

Why regular HVAC/clean room Validation is important statutory requirement in Pharma or medical device Industry?

 

Only putting in a HVAC system isn't always completely effective until a regular validation has been carried out to confirm that the installed system is running as per the set parameters and design. Validation means checking, verifying, or confirming the accuracy of a process or system or facility. After performing validation a documented evidence of the findings in form of reports are kept for record which are very important at the time of Audits. Validation reports helps the quality teams to ensure the consistency of established processes/ systems.

The results of validation also helps the maintenance team to take preventive measure on time before the breakdown of the system along with planning the annual maintenance program of the system. HVAC Validation facilitates to find out the deviations incurred in the system and the design during the process over the time. Validation also reduces the risk of non-compliances with regulatory standards. The production capacity of manufacturing units can be optimised by reducing the chances of rejection on account of bad quality.  

It is important here to mention that regular validation of HVAC/ clean room is a mandatory requirement under various regulation viz. FDA (food & Drug Administration), Schedule M of Drugs & Cosmetic Act 1940 and Rules 1945, MHRA (Medicines and Healthcare products Regulatory Agency of UK) and ISO.

 

When should the clean room validation for pharma companies be done?

 

As per Schedule M of The Drugs & Cosmetic Act 1940 and Rules 1945

( a ) Particulate monitoring in air – 6 Monthly

(b)  HEPA filter integrity testing (smoke testing) – Yearly

(c) Air change rates – 6 monthly

(d) Air pressure differentials – Daily

(e) Temperature and humidity – Daily

(f) Microbiological monitoring by settle plates and/or swabs in aseptic areas – Daily, and at decreased frequency in other areas

Note : The above frequencies of monitoring shall be changed as per the requirements and load in individual cases

 

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POST DATE

4/3/2020 4:06:01 PM POST BY: Admin

Medical Devices notified as Drugs with effect From 1st April 2020

 

MINISTRY OF CHEMICALS AND FERTILIZERS

             (Department of Pharmaceuticals)

(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)

                                 ORDER

       New Delhi, the 31st March, 2020

S.O. 1232(E).—In pursuance of Notification No. S.O. 648(E) dated 11th February 2020 issued by Ministry of Health & Family Welfare, Government of India whereby Medical Devices intended for use in human beings or animals have been notified as Drugs with effect from 1st April 2020; all Medical Devices shall accordingly be governed under the provisions of the Drug (Price Control) Order, 2013.

[PN/206/74/2020/F/F. No. 8(74)/2020/DP/NPPA/Div.-II]

ALOK RANJAN, Asstt. Director

http://www.tescroom.com/services.aspx

 

                                                              

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POST DATE

3/20/2020 2:13:31 PM POST BY: Admin

Happy International Women Day

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POST DATE

1/14/2020 11:39:03 AM POST BY: Admin

Regular Monitoring of Indoor air quality of Operation Theater (OT) can prevent the chances of Surgical Site Infections (SSI)

 Sterility means free from viable life which has the tendency to reproduce and spread disease causing germs and bacteria which if uncontrolled gives birth to dangerous viruses. Sterility alone can not be achieved only by cleaning or applying antiseptic cleaners on the equipment or furniture. Sufficient supply of good air quality within the OT is the other tool which is required to maintain microorganism free environment during the operations.

Monitoring of Indoor air quality or environment plays a major role in defining the hygiene of an OT. In OTs chances are higher that microorganisms suspended in air get settled in operation site which continues to grow later leading to post-operative surgical site infections. An OT requires a controlled environment where air should be purified, humidity under control and sufficient Air exchange. Thus a clean air should circulate with every minute taking out the toxins from the OT out of it. The more controlled air exchange in an OT the more it will prevent reproduction of any kind of bacteria or microorganisms in the environment. Thus it is equally important for Hospital administration and management to ensure that air quality of OTs are monitored regularly. But alone air exchange will not serve the purpose. How efficiently HEPA filters performing also determine the quality of indoor environment. HEPA filters, keeping dust particles out of the OTs, need to checked every six months to ensure that filters installed are working properly and not chocked. 

NABH guidelines also under the maintenance of system suggest -Validation of system should be done every 6 months and as per ISO 14644 standards. This should include:

• Air particulate count

• Temperature and Humidity check

• Air Change Rate Calculation

• Air velocity at outlet of terminal filtration unit /filters

• Pressure Differential levels of the OT with respect to ambient / adjoining areas

• Validation of HEPA Filters by appropriate tests. 

Do you want to check the Indoor Enviornment or Air quality of your Operation Theatre, reach us at sales@tescroom.com

Photo by- EyeMed Hospital

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POST DATE

1/3/2020 12:59:32 PM POST BY: Admin

Happy New Year 2020

Thank You 2019 for being so wonderful. Time for new Beginning and Adventures. Wishing you all a very Happy New Year 2020 hashtaghappynewyear2020 hashtagcleanrooms hashtagvalidation hashtagmedicaldevices hashtaghealthcarequality hashtagautomobiles hashtaglaboratories hashtagfmcg hashtagmaintenance hashtaghospital hashtagopportunites hashtagindia hashtagmarketing

 

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