Overview of PPE Kit Certification

Personal protective equipment, hand hygiene, and waste management materials are some of the measures that are adopted during infection prevention. Personal protective equipment is the set of garments that acts as a shield by protecting the health care workers or any other person from getting infected. PPE kit consists of gloves, masks and gown, and in case of high airborne infection, it includes goggles, faces shield, headcover and rubber boots as well. The purpose of obtaining PPE kit certification is to manufacture PPE equipment.

PPE industries deal with complexity, competitiveness and challenges, which ultimately lead to an improvement in the quality of personal protective equipment. Also dealing with problems helps the industry in improving margins, quality and reduce the cost of production. Irrespective of the type of PPE product you are manufacturing Corpbiz stand by you during the testing and certification requirements for PPE.

PPE Kit Certification during COVID-19

Lately, the Union Ministry of Textile, India has come out with a certain set of guidelines that are essential for Personal Protective Equipment test centres and manufacturing units to adhere to. Instances have been recorded where manufacturers were caught selling PPEs to the private hospitals that nearly failed the quality tests at the test centres.

Current pandemic COVID-19 has forced the Ministry of Health & Family Welfare, Government of India, to formulate strict guidelines regarding the manufacturing and testing process of PPE related to which the ministry has already published comprehensive guidelines.

Though, Ministry of Textile has happened to issue a notice about the guidelines that are to be followed with immediate effect that will guarantee the refinement in the quality of Personal Protective Equipment Body Coveralls.

The notification states that officially there are only two recognized laboratories responsible for carrying out test on Body Coveralls (PPE) in India, South India Textile Research Association (SITRA), Coimbatore and Defence Research & Development Establishment (DRDE), Gwalior.

Guidelines cover strict rules to be adhered by the testing centres and manufacturing units, such as, generating Unique Certification Code (UCC-COVID-19) for each proto-type test conducted at SITRA/DRDE, manufacturing of PPE garment in accordance with material and quality according to the tested and certified prototype, putting up tamper-proof stickers which include Name of Manufacturer, SITRA/DRDE Unique Identification Code, Test Standard, Date of Manufacturing and Batch.

Testing and Certification of Samples of PPE Body Coverall for Covid-19, by INMAS

Government of India has assigned Institute of Nuclear Medicine & Allied Sciences (INMAS) the responsibility to test the Personal Protective Equipment (PPE) Body Coverall Samples for COVID-19, submitted by the potential manufacturers in India. A Synthetic Blood Penetration Resistance Test is conducted, and the INMAS presents test reports.

Benefits of Personal Protective Equipment

Cleaning and hygiene play an important role in protecting you from life-threatening viruses and reliable disinfectant cleaners. Investing in PPE kit can deliver numerous benefits to you and your staff, and one should not take PPE Kit Certification for granted.

Your motive is to keep your employees safe by reducing their risk of getting infected. Below are some benefits of PPE Kit

• Prevention from Exposure
• Minimize the Level of Risk
• Protects the Spread of Germs

Let's dig in and discuss these benefits in detail.

• Prevention from Exposure

  In layman term, prevention from exposure means protecting your employees from harmful bacteria so that they will not get sick. It is the responsibility of the employer to make sure that his employees are secured and protected after performing their duties.

• Minimize the Level of Risk

  In case of disclosure to any harmful bacteria or germs, PPE kit will help in minimizing the level of risk and potentially saving the employee’s life.

• Protects the Spread of Germs

  PPE kit acts as a lifesaver by averting the growth of germs and bacteria from one individual to another. For example, often, the dentist wears headgear during the process of treatment to protect themselves from getting infected from bacteria.

Points to Remember While Using PPE

• PPEs do not serve as an alternative to preventive public health measures. Etiquettes such as hand hygiene, proper cleaning should be followed adequately.
• Try to follow social distancing by maintaining a distance of at least 1 metre from people around you and suspects as well.
• Try to adhere to the protocol of laid down for getting rid of PPEs as detailed in infection prevention and control guideline available on the website of MOHFW.

Personal Protection Equipment (PPE) – Specification

Once you have obtained PPE Kit Certification, make sure to deliver provide the following items in the PPE kit:

Gloves

• Nitrile
• Non-sterile
• Powder free
• Outer gloves preferably reach mid-forearm (minimum 280 mm total length)
• Different sizes

Coverall (medium and large)

• Impermeable to blood and body fluids
• Single use
• Avoid colors such as black
• Go for light colors as they help better in detecting possible contamination
• Thumb/finger loops to anchor sleeves in place
• Quality complaint related to the following standards

  Meets or exceeds ISO 16603 class 3 exposure pressure or equivalent

Goggles

• Well fitting transparent glasses with zero power plus covered from all sides with adjustable holders
• Flexible frame that fits easily to all face contour without much of a pressure
• Cover eyes and the surrounding areas
• Fog resistant
• Scratch resistant
• Adjustable band which do not loose while performing clinical activity
• Indirect venting which helps in reducing fogging
• Re-usable or disposable
• Quality complaint with the below standards or equivalent:

  a. EU standard directive 86/686/EEC, EN 166/2002

  b. ANSI/SEA Z87.1-2010

N-95 Masks

• Shape that will not subside simply
• High filtration efficiency
• Breathability is efficient with expiratory valve
• Quality complaint with standards for medical N95 respirator:

  a. NIOSH N95, EN 149FFP2, or equivalent

• Fluid resistance: minimum 80mmHg pressure based on ASTM F1862, ISO 22609, or equivalent
• Quality complaint related to standards to particulate respirator that can be worn with full-face shield.

Shoe Covers

• Made up of the same fabric as of coverall
• Should cover the entire shoe and reach above ankles

Face Shield

• Made out of clear plastic and provides good visibility to both the wearer and patient
• Adjustable band to attach firmly around the head and fit snugly against the forehead
• Fog resistant
• Completely covers the sides and length of the face
• Re-usable or disposable
• Quality complaint with the below standards or equivalent:

  a. EU standard directive 86/686/EEC, EN 166/2002

  b. ANSI/SEA Z87.1-2010

How to get CE Certified to meet Face Mask and PPE Kit Certification Requirement?

The manufacturer is responsible to assure conformity with all the requirements. It is crucial for face mask and PPE kit to meet the requirements of applicable EU directives. However, no need arises to get a license to affix the CE marking to products but before going for that, make sure to adhere to the following:

• Have complete knowledge regarding the EU requirement for your product
• Verify that your products are being manufactured following the norms of relevant EU requirements
• Check whether the products required are tested by a notified body
• Examine your product
• Check whether the products have successfully met the technical requirement
• Affix CE marking and sign an EU declaration of conformity

Prior Requirements of Affixing the CE Marking

Bodies like EU manufacturers, distributors of products, and importers who work hard with the motive to sell their product in the EU market are the bodies responsible behind CE marking.

• Before products get introduced in the market, CE marking and EU directives are the crucial points to consider
• Manufacturers enjoy the right to assess which EU directives will be applicable in case of their products
• Compliance of the product decides the placement of the product in the market. Considering all the provisions applicable guidelines and instructions, and if the process of conformity assessment has taken place in a secure way.
• Manufacturer now can sign an EU declaration of conformity EU standards
• It affixes the CE marking on the product.
• It is necessary for a CE marking to be noticeable and indelible.

CE certification allows the commercialization of medical products that has become critical nowadays because of the Coronavirus crisis ravaging the whole world. Manufacturers who are working on the manufacturing of legal, medical devices and kits must responsibly by managing regulatory compliance and bringing their products under the roof of CE marking. Contact our regulatory experts who are always ready to help you out in obtaining CE Certification for your face mask and PPE kit.

GMP Certification Related to Face Masks and Medical Devices

GMP certification is related to the natural and pharmaceutical product manufacturing. Good Manufacturing Practices (GMP) is a system which consists of predefined set of guidelines which ensures that your products are safe and healthy to use as their production has carried out following the quality norms. GMP encompasses all the production aspects starting from the initial materials, premises and equipment to the staff’s health and hygiene maintenance.

Make sure to organise the things at each step in such a way that obtaining access to Documented proof pertaining to quality maintenance throughout the process becomes feasible and readily available. One of the functions of GMP include covering the defects and complaints related to the products.

Fundamental Principles Related to GMP Guidelines and GMP Certification

• Manufacturing processes should be clearly defined as well as controlled.
• Any changes related to manufacturing processes must go under evaluation.
• Procedures and instructions should be free from ambiguity and vagueness.
• Operators have received the training in such a manner that they will be able to carry out and Document procedures.

Any complaint regarding the marketed products will be thoroughly examined and inspected. The investigation will be conducted on the basis of the quality defects. The need will arise to adopt appropriate measures to curb the flaws in products and averting recurrence at any cost.

GMP Certification not only focuses on the manufacturing process of the actual product but it also ensures that products adhere to the quality control of issues of administration like those of record maintaining, qualifications of personnel, sanitation as well as cleanliness along with validation of the process. Companies with GMP certification guarantees that their manufactured products are high in terms of quality and maintenance and match the standards at the world level.

GMP Certification

The first step of obtaining this certification is to complete an application process. An authorized person is responsible to file an application for GMP certification inside the company seeking the certification.

GMP certificate will issued in the name of the registered company and will remain valid till three years. This certificate will reflect the scope of certification along with the name and the address of the manufacturing place of the company.

FDA Certification

The Food and Drug Administration plays an important role in curbing the infectious deadly diseases. The Food and Drug Administration is setting its sights to provide time to time direction to give wings to the response efforts to this Pandemic. With the issue of this guidance, the FDA is providing a policy to make the general use face masks available to the general public and respirators for health care professionals.

This policy will remain in action only during the time of public health emergency related to COVID-19 as proclaimed by the Health and Human Services Department (HHS Department).

FDA Approval for Medical Devices

FDA is known for regulating a wide array of products like a drug, food, cosmetics as well as medical devices. There are many set standards of FDA on which it measures the quality of products. The requirements vary from one product category to another. Very often, class 1 and class 2 medical devices do not need approval by the Food and Drug Administration. Class 3 medical devices must have FDA approval for the marketing of products. Class 2 medical devices demand a marketing clearance from the FDA side. FDA registration and device listing are mandatory for all medical device establishments.

IMA Approval

Indian Medical Association remains in touch with the National Medical Associations of different countries to share relevant information and spread awareness about the best practices to be adopted at Indian and International level. Approval of the Indian Medical Association plays an important role, especially in the time of grave medical emergency. Their stamp of approval works for the benefit of the products, and it’s a sign that the products are healthy since they are approved by IMA.