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Importance of hygiene and sanitation in ‘the time of Covid’

Dr Priya Digarse
Thursday, January 28, 2021, 08:00 Hrs  [IST]

The world is embracing changes and taking proactive measures to successfully navigate through COVID-19. The global pandemic can may be associated with numerous short and long-term impacts on the health market, mainly the pharmaceutical sector. In terms of volume, India is the third-largest pharmaceutical market globally with exports standing at $19 billion in 2018-19.

Hygiene industry on an upswing
The havoc wreaked by COVID-19 has surely been a catalyst, but now with the greater understanding of the present and future risks, it is expected that the societal outlook on hygiene will change permanently. The increased demand for products like disinfectants, masks, sanitisers, soaps etc. will continue to grow even in the post-pandemic world.

Whether it is pollution or the annually recurring viral diseases, people will now be a lot more aware and willing to stay safe by observing hygiene protocols. The virus will surely be contained soon and there will be vaccines in another year or two to cure its future occurrences. However, the hygiene industry in India as well as on a global scale is on an upswing and will grow stronger even after normalcy resumes.

A high level of sanitation and hygiene should be practised in every aspect of the manufacture of drug products. The scope of sanitation and hygiene covers personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene.

Importance of hygiene and sanitation
Proper hygiene is essential in the pharmaceutical industry to prevent any kind of contamination that can affect the quality of medicinal products. When it comes to delivering highest quality standards of pharmaceutical products, key hygiene factors need to be upheld. High levels of cleanliness and sanitation must be practiced through all stages of manufacturing through a comprehensive screening – from the personnel working in manufacturing plant to the production process.

Every pharmaceutical company should adhere to strict hygiene laws to ensure high-quality drugs are manufactured and packaged in a contamination-free environment.

Impact of Covid on hygiene and sanitation
Personnel conducting visual inspections should also undergo periodic eye examinations.

Direct contact should be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product.

To ensure protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized.

Personal medicines should not be allowed in manufacturing area, laboratory and storage areas or in any other areas where they might adversely influence product quality. 

As such the pharmaceutical industry does take very good care to avoid cross contaminations as part of Good Manufacturing Practices (GMP). But now keeping in mind seriousness of virus spread, the pharmaceutical industry has to take precautions to avoid transmission & spread during travel in buses, entry & exit procedures, change rooms, avoid hand touch to doors, handles etc. at office work places and throughout the manufacturing operations at site.

As per WHO, key major steps to protect against the infection are:

  • Social distancing
  • Use of masks/face- shields
  • Frequent washing of hands with soap and water or sanitisation with proper sanitisers containing min. 70 per cent  alcohol.
  • Segregation of staff in essential & non-essential at manufacturing site.
  • Non-essential staff to work from home
Production hygiene
For GMP-compliant production unit, it is crucial to follow tailored hygiene strategies to ensure safe implementation and use of products in life science, biotechnology, cosmetic and medical applications.

To prevent contamination and maintain highest standards of sanitation, pharmaceutical manufacturing companies must implement use of classical, sterile or microbial filtered disinfectants in addition to manual disinfection process.

Innovative hydrogen peroxide vapour generators are streamlining the process of maintaining hygiene in production facilities. These powerful machineries facilitate fast and effective decontamination of the manufacturing unit and equipment.

The concept of clean room is also gaining remarkable popularity in the pharmaceutical industry. A controlled environment is designed for specialised pharmaceutical manufacturing that maintains a low level of airborne microbes, dust, chemical vapours and aerosol particles.

Significant product contamination may also occur at the time of loading or unloading the medicinal products. Therefore, it is essential to check the premises carefully to identify dirty spots or breeding zones, and clean the areas with disinfectants that are lab-tested and compliant with industry safety standards.

Ensure all cleaning equipment meet key requirements of optimal ergonomics, sterilisation and clean room requirements

The storage areas and walkways should be cemented to minimise the risk of spreading impurities
Following these basic hygiene practices will help maintain optimal sanitation standards in pharmaceutical production plants and ensure the drug quality remains unaffected.

Personnel hygiene
Despite effective measures taken to maintain hygiene for production facilities, equipment, raw materials and product packaging, one of the primary sources of contamination are human beings.

Educate and train all personnel working in the pharmaceutical sector regarding the importance of hygiene

Implement use of hygienic workwear in specified work areas such as production facility, storage areas, loading & unloading unit etc. Proper training should also give regarding not using the hygiene clothing when away from the manufacturing environment or using the canteen, smoking area and toilets

Such hygienic workwear should be available in sufficient numbers and must have a suitable design to prevent product contamination. It should also include caps for scalp hair and snoods for moustaches and beards

Laundering of workwear should be implemented only by an approved contractor or in-house facility conforming to industry-defined criteria that validates the entire process. The following measures must be undertaken to ensure highest standards of hygiene in workwear laundering:
  • Appropriate segregation of dirty and cleaned clothing
  • Effective cleaning of workwear following industry standards
  • Cleaned clothing must be supplied in contamination-free bags or covers
  • Proper verification and validation of the laundry process should be in place and practiced thoroughly
Implement use of high-performance hand disinfectants and dispensing systems to meet the highest standards of hand hygiene – one of the most critical preventive measures to avert the risk of germ & impurity transmission by the hands of the personnel.

The use of proper and hygienic workwear is crucial to maintain high standards of pharmaceutical safety and ensure wellbeing of the end consumers. At the same time, effective measures must be taken to facilitate high quality cleaning, sterilisation and delivery of workwear to uphold hygiene at the workplace.

Plant and surface disinfection
In addition to practicing effective production hygiene, proper measures should also be taken to disinfect the plant and surface.
  • Use high-quality, industry-approved sterilisation products that are tested for efficacy,
  • user friendliness and occupational safety
  • Ensure the plant walls, ceilings and floors are washable; regular cleaning and scrubbing is important to avoid impurity accumulation and spreading contaminants
Mitigation measures
Following are some of the mitigation measures taken by pharmaceutical industries to maintain good hygiene levels.
  • Set up a Covid HR team to monitor the status of every employee in the organisation on the following parameters: – Where they are currently situated – their health status – their current activity status – disclosure of their family members’ health issues.
  • Daily monitoring (across all locations).
  • Launch a digital employee health declaration system to track employee well-being and comply with administrative reporting requirements.
  • Set up a panel of doctors to provide virtual guidance to employees on health issues. (COVID HR team to monitor).
  • Prepare a roster of employees operating in the plant on a rotation basis, keeping in mind risk assessment, location proximity, executive health reports, and annual checkup reports.
  • Develop and disseminate/communicate strict protocols for staff working at plants and from home.
  • Conduct a periodic medical check-up, including a thermal check-up/scanning at entry point for all employees. In case anyone is found positive for COVID -19, – Ask employees to track all contact with co-workers and visitors in case they develop symptoms. Spread of infection across employees working from home and operating within plants Risk COVID-19 response for Pharma companies |
  • Enforce/implement the 14-day quarantine for employees returning from a restricted zone.
  • Permit access to shop floor only after a doctor’s certificate, and if possible, also test the employees for COVID-19 symptoms. Contamination from employees returning from a tour/restricted zone Risk Mitigation measures Restrict contractor access to plant or office operations. In case contractor access is inevitable,
  • Confirm from third parties/vendors that no employees are infected, and measures are being taken to detect the virus.
  • Set up thermal scanning/check-up at all entry points.
  • Review if the contractor has acquired health insurance for its staff.
  • Declare that staff has not been forced to come to work under the current scenario. Contract employee health issues Risk – Ask employees to report confirmed cases of themselves or family members, and stay at home for 14 days or until cleared by a doctor. – Isolate employees diagnosed at work, and immediately disinfect anything they have come in contact with. Notify other employees and clients that may have been in contact with the individual, without releasing their name.
  • Document a policy pertaining to work from home, if not available.
  • Restrict non-essential travel (domestic/ international) and promote flexible working arrangements. • Communicate emergency toll-free numbers to handle any crisis that may come up.
  • Educate employees on COVID-19 symptoms and prevention through video/audio conferences.
  • Encourage employees to speak to a counsellor for advice on managing stress and boosting morale.
  • Communicate personal hygiene good practices to employees, and educate them on social distancing measures.
  • Provide masks, wipes, and other personal hygiene products to on-site employees.
  • Changes in sanitation procedures taking COVID-19 into account
  • Clean and sanitize nonproduction areas (such as offices, elevators, break rooms, changing rooms, and restrooms) more frequently.
  • Update existing procedures to institute more frequent cleaning, sanitization, and/or sterilization of surfaces in the production areas, particularly surfaces that are contacted frequently, such as door handles, equipment latches, bench/counter tops, and control panels. Special attention should be paid to sanitizing/sterilizing equipment and product contact surfaces.
  • Consider expanding existing procedures to include using gloves, face masks, and/or gowning where such measures were not previously required.
  • Consider further restrictions on employee access to any manufacturing area, beyond that required by CGMP regulations and recommended by Agency guidance18 and normal practice, to limit the possibility of contamination.
If a potential or actual viral contamination event is identified, drug manufacturers should promptly clean, disinfect, sanitize, and if necessary, sterilize affected equipment, surfaces, production areas, and facilities, before resuming manufacturing. If supplies of single-use masks and other garb used to control contamination during manufacturing are low, they should be prioritized for use in sterile manufacturing operations.

Premises
Premises must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out.

General
The layout and design of premises must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.
Premises should be situated in an environment that, when considered together with measures to protect the manufacturing process, presents minimum risk of causing any contamination of materials or products. Premises should be designed to ensure the logical flow of materials and personnel.

Ancillary areas
Rest and refreshment rooms should be separate from manufacturing and control areas.
Facilities for changing and storing clothes and for washing and toilet purposes should be easily accessible and appropriate for the number of users. Toilets should not communicate directly with production or storage areas.

Storage areas  
Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products with proper separation and segregation: starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.

Receiving and dispatch bays should be separated and protect materials and products from the weather. Receiving areas should be designed and equipped to allow containers of incoming materials to be cleaned if necessary before storage.

Where quarantine status is ensured by storage in separate areas, these areas must be clearly marked and their access restricted to authorized personnel. Any system replacing the physical quarantine should give equivalent security.

Production areas
In order to minimize the risk of a serious medical hazard due to cross contamination, dedicated and self-contained facilities must be available for the production of particular pharmaceutical products, such as highly sensitizing materials (e.g. penicillins) or biological preparations (e.g. live micro-organisms).

Drains should be of adequate size and designed and equipped to prevent back-flow. Open channels should be avoided where possible, but if they are necessary, they should be shallow to facilitate cleaning and disinfection.

Production areas should be effectively ventilated, with air-control facilities (including filtration of air to a sufficient level to prevent contamination and cross-contamination, as well as control of temperature and, where necessary, humidity) appropriate to the products handled, to the operations undertaken and to the external environment.

Quality control laboratories should be separated from production areas. Areas where biological, microbiological or radioisotope test methods are employed should be separated from each other.

Equipment
Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.

Equipment should be installed in such a way as to minimize any risk of error or of contamination.  Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.

Laboratory equipment and instruments should be suited to the testing procedures undertaken.

Materials
The main objective of a pharmaceutical plant is to produce finished products for patients’ use from a combination of materials (starting and packaging).

Materials include starting materials, packaging materials, gases, solvents, process aids, reagents and labelling materials.

General
No materials used for operations such as cleaning, lubrication of equipment and pest control, should come into direct contact with the product. Where possible, such materials should be of a suitable grade (e.g., food grade) to minimize health risks.

All incoming materials and finished products should be quarantined immediately after receipt or processing, until they are released for use or distribution.

 Starting materials
Starting materials should be purchased only from approved suppliers and, where possible, directly from the producer. It is also recommended that the specifications established by the manufacturer for the starting materials be discussed with the suppliers.

For each consignment, the containers should be checked for at least integrity of package and seal and for correspondence between the order, the delivery note, and the supplier’s labels.

All incoming materials should be checked to ensure that the consignment corresponds to the order. Containers should be cleaned where necessary and labelled, if required, with the prescribed information. Where additional labels are attached to containers, the original information should not be lost.

Intermediate and bulk products
Intermediate and bulk products should be kept under appropriate conditions.
Intermediate and bulk products purchased as such should be handled on receipt as though they were starting materials.

Finished products
Finished products should be held in quarantine until their final release, after which they should be stored as usable stock under conditions established by the manufacturer.

Balancing workforce, optimization and controls during Covid
During COVID-19, Pharma manufacturing companies made many adjustments to modus operandi. That includes accommodating remote workforce, social distancing when in person, wearing masks and gloves, and avoiding any possibility of spreading the coronavirus. Mainly while dealing with organic material within the raw material ingredients, additional testing is needed before the drug passes Quality and is deemed ‘in spec’. The extra impetus has led to newer Standard Operating Procedures in operations and quality when it involves batch production through batch records.

While these changes and concerns are bound to affect the pharmaceutical industry’s workings, proper management, technology, and software to navigate these challenging times has enabled the pharmaceutical sector to rise to the occasion.

Hence Although Covid-19 brought various said and unsaid challenges for every sector. Pharmaceutical industry geared up rigorously to cope up and emerge as winner by implementing changes in hygiene and sanitation procedures keeping operations unaffected. Be it China’s pressure, be it producing Covid-19 vaccine, be it financial and humanitarian losses, Pharmaceutical industry revamped the technical procedures thus taking care of hygiene and sanitation to maintain quality of vaccines/ medicines going in the global market.

(The author is head of department, Department of Cosmetics and Perfumery, Maratha Vidya Prasarak)

 

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