PPE Kit Certification : Overview and Guidelines

After the outbreak of COVID-19 pandemic, the inadequate availability for personal protective equipment (PPE) has resulted in complex issue in India. PPE is one of the important measure that is adopted to prevent the infection of Coronavirus. Before this pandemic, India was not producing any PPE kit. This forced the Ministry of Health & Family Welfare, Government of India, to formulate strict guidelines regarding the testing and manufacturing process of PPE. Further, Government has published comprehensive guidelines on this matter. India, now, has achieved a target of producing 2.06 lakh kits daily. In this article, we will discuss about the PPE Kit Certification and the important guidelines as issued by the multiple Ministries of India.

Meaning of PPE Kit

PPE (Personal Protective Equipment) is an item of garment that acts as a protective shield mainly for doctors, nurses health care workers and other people to avoid getting infection from highly contagious viruses like COVID-19.

PPE Kit acts as a barrier between the healthcare worker and the infected person or body fluids. Hence, it largely reduces the spread of risk of COVID-19. PPE Kit mainly consists of masks and gown, gloves, face shield, body suits, goggles, shoe covers and head covers.

Advantages of Personal Protective Equipment

Personal Hygiene, Cleaning plays an essential role in keeping you safe and protective from life threatening viruses or highly contagious diseases. The risk of getting infected highly reduces by using PPE Kits. One should obtain PPE Kit certification before planning to manufacture such kits. PPE Kits are being considered as life saver equipment. Some of the benefits of PPE Kit are as follows:

• Prevention from getting exposed with any other person who is infected. Hence, you can avoid illness o your body
• Minimization of risk of catching viruses
• Helps in protecting and avoiding the spread of bacteria and germs.

Important points to remember while using PPE Kit

• PPE’s do not serve as an substitute to prevent such emergency health measures. Hence, basic etiquettes like washing hand, sanitization, disinfectants need to be followed strictly.
• Strictly follow social distancing from another person by maintaining a distance of at least 2 metres.
• Follow protocols as laid down by the government officials to get rid of PPE’s

PPE Kit Certification, Guidelines and Testing

Ministry of Textile has issued various guidelines for the testing centers and manufacturing units of PPE. The main motive of such guidelines is to simplify and streamline the process of manufacturing and testing of PPE, along with ensuring and maintaining the quality of PPE coveralls.

On the other hand, Ministry of Health and Family Welfare has recently issued few guidelines for workers engaged in health care facilities including professionals working at dedicated quarantine centers, primary health care centers, laboratories and at any other health care facility. Such guidelines mainly focuses on different types of PPE’s used at various health care centers.

Further, Institute of Nuclear Medicine and Allied Services (INMAS) is responsible to test the PPE full body or notified body coverall samples submitted in India. Such test is known as Synthetic Blood Penetration Resistance Test

CE Certification for manufacturing Face Mask and PPE Kit

The manufacturer, at all times, needs to ensure that all the requirements which are important for face mask and PPE kit are met as per the EU guidelines. The following must be taken care of to get a license to affix the CE marking to products:

• Make sure that you have complete knowledge with respect to requirement of EU for your product
• Verify that the products are being manufactured as per the relevant norms of EU Requirements
• A Notified body must check and test all the products righteously
• All the PPE products should be properly examined and must met the technical requirement
• Affix marking of CE and sign a declaration of conformity with EU

Note: CE Certification allows the manufacturer to commercialize its medical products as it is essentially required to aware public during this period of crisis of COVID.

Contact our legal experts who can help you in obtaining CE Certification for face masks and PPE Kit

Validity of CE Certification

CE Certification on the products remain valid for three years. However, devices or products which have high risk remain valid for just one year.

GMP Certification for Face Masks and PPE Kit

Goods Manufacturing Practises (GMP) certification helps in dealing with the manufacturing of pharmaceutical and natural products which includes Face Masks and PPE Kit. Such guidelines ensures that the products are safe to use and complies with the quality standards which results in maintaining hygiene, health and safety . GMP Certification also includes initial material, equipment, premises, production aspects etc.

Guidelines for GMP Certification

• Process of manufacturing must be clearly stated, defined and controlled;
• Any kind of changes regarding the manufacturing processes must go through strict examination, verification and evaluation;
• Instructions and processes of manufacturing must be free from any kind of uncertainty or ambiguity;
• The operators must receive the training in a proper way through which they can carry out document procedures.

Final Words

PPE Kit Certification and face masks have to undergo proper certification as per the CE and GMP guidelines. Industries dealing with PPE deals with various complexity and challenges to provide the good quality Personal Protective Equipment.

Legal Window helps you at the time of testing and certification of PPE, irrespective of the type of PPE Kit you are manufacturing.