Safety for Success
Any pharmaceutical company is only as good as its last blockbuster, or rather as good as is being researched and tested in its R&D labs. The laboratory, whether R&D or QC, is thus at the heart of the success of a pharma company; nay the entire industry. From such labs, emerge best selling medicines. Such labs also test every batch of medicines going into the market. Pharma companies accordingly invest a sizable chunk of their capex to buy the latest high tech equipment, hire the best talent and put in place safety and security measures to protect its people and the data generated.
Creating a lab is one thing, running it as per regulations and getting it certified is a different task altogether. One important factor is maintaining a safe environment in these laboratories and this aspect is globally governed by Environmental, Health and Safety (EHS), Occupational Safety and Health Act (OSHA) guidelines. India follows the same guidelines.
 “India is at par with global standards when it comes to practicing safety. It is done as per the EHS guidelines.”Surendra Chavan, Founder & CTO, Quantimmune Solutions |
Speaking about the trends in lab safety, Surendra Chavan, Founder and CTO, Quantimmune Solutions, a Mumbai-based CRO says, “Staff undergo safety trainings at regular intervals which involves fire-fighting, spillage control etc. Mock drills are conducted. Alarm systems have been installed and people are trained to respond to the same. Similarly designated individuals act as safety co-ordinators who become a link between the lab staff and the EHS department. Personal Protective Equipment (PPE) which includes mask, gloves, goggles etc. are worn by staff while working in the lab.”
 “The labs are designed in an ergonomic manner so that material and man movements are free.”Salil Sansare, Director, Labguard India |
Salil Sansare, Director, Labguard India, a leading manufacturer of safety features like fume hoods and laboratory furniture, which also offers lab design services, provides more details on how pharma companies can meet lab safety standards. According to him, labs are designed in an ergonomic manner so that material and man movements are free. Separate chemical storages are defined. An adequate number of eye wash stations and safety showers are installed in the lab to handle emergencies. Their locations in the lab are also carefully decided based on workflow patterns.
Sansare describes many steps taken to ensure lab safety. “Lab users need to check the norms to use flameproof electrical fittings. Good level of efforts are made to ensure that labs are electrically safe,” informs Sansare. Flameproof electrical fittings are important as in the last few years quite a few mishaps were reported in pharma plants across India. Some of these incidences were suspected to be the outcomes of electrical short circuits.
Sansare adds, “Lab ventilation is also given a lot of importance. More and more labs are well ventilated or even air conditioned. VAV systems are integrated into the lab’s heating, ventilation, and air conditioning (HVAC) system to achieve comfort and safety in the lab. Fume hood performance tests are carried out as per ASHRAE-110:1995 or EN-14175:2003 standard to ensure that the fume hoods are safe to use and not merely a ventilated box.”
Employee, a risk carrier
Laboratory staff is perhaps the most mobile object in any lab. Disease carrying individuals can spread disease causing bacteria to different parts of the lab. So they can also be classified as a risk factor to the laboratory.
 “As per the GLP norms, all laboratories and organisations carrying out testing, calibration, validation in India have to adhere to Schedule L 1 guidelines.”Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals |
“Laboratory management should take the health and safety of employees into account. As per GLP norms, all laboratory persons should have annual medical examination to know their physical fitness/ health status. An individual who has an illness/ disease which may adversely affect the quality and integrity of the study should be excluded from direct contact with test systems and from test and control articles until full recovery from that illness/ disease. After a medical fitness test approval is obtained, he/ she can again perform regular laboratory work. It can be certainly classified under a safety risk to the lab,” opines Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals.
Experiments that involve animals are at higher risks due to the staff that has health issues. There are chances of zoonotic disease, which are transmissible between animals and man. Intox Laboratories perform toxicological studies and lab animals are integral part of their regular studies.
 “An appropriate immunisation (vaccination) schedule should be adopted for people working with animals.” Dr Mukul Pore, Director, Intox Laboratories |
Dr Mukul Pore, Director, Intox Laboratories, says, “If any person working with animals is found to have any communicable disease (zoonotic disease) which would affect the studies and other individuals working in the facility, he/she shall not be allowed to work in the animal house. The management should organise medical check ups of all the staff and workers at the time of joining and at least once a year. This examination should be conducted by a registered medical practitioner.”
While talking about more safety precautions that are to be taken while working in the animal labs, Pore informs, “Potential hazards while working with animals include zoonoses, chemical, biologic and physical hazards (e.g. radiation and allergies). Personnel working in the animal house or laboratory should be trained for zoonoses, unusual conditions or agents that might be part of experimental procedures (e.g. use of human tissue in immunocompromised animals), handling of waste material, personal hygiene etc. Researchers should be instructed (enforced) to use Personal Protective Equipments (protective clothing, gloves, masks, face shields, head cover, coats, shoes or shoe covers) to avoid exposure to urine, faeces, and allergenic agents associated with animal subjects. Outer garments worn in the animal rooms should not be worn outside the animal facility. An appropriate immunisation (vaccination) schedule should be adopted for people working with animals. It is important to immunise animal care personnel against tetanus, rabies (if working with species like dogs, primates etc) or hepatitis B virus (if working with human blood or human tissues).”
Chavan says, “People working in the lab periodically undergo medical and or physical evaluation and based upon the clean bill of health they are allowed to work in the lab.”
Safety audits
Irrespective of the purpose and size, regular examination of safety measurements at the lab is recommended by concerned authorities. Every lab has to perform safety audits as directed by the domestic and international norms.
Dahatonde informs, “The GLP guidance and norms, based on the Organisation for Economic Cooperation and Development (OECD) principles of GLP has now become a national system for GLP compliance monitoring and for recognition/certification of test facilities/ laboratories engaged in conducting safety studies, concerned with the effect of chemicals/pharma products on human health and environment. As per the GLP norms, all laboratories and organisations carrying out testing, calibration, validation in India have to adhere to Schedule L 1 guidelines. Global regulatory norms are based on OECD guidelines. As per guidelines, the period of safety audit is once in a year by external experts and internal audit as per planned schedule.”
He adds, “The GLP accredited lab should have qualified safety personnel to maintain and to implement documented safety system. The safety personnel should prepare a schedule for technical audit of the laboratory by an expert. Internal safety audits should be done to assure the safety measure with appropriate checklist, to verify that the operations continue to comply with the requirements of safety system and regulatory authorities. It also needs periodic checking of all safety equipment and accessories along with annual service contracts with the safety equipment suppliers to ensure the performance of the equipment.”
According to Chavan, safety audits are based upon the Standard Operating Procedure (SOP) adopted by the company, keeping global practices in mind.
Training matters
According to the industry experts, despite well defined safety norms for labs, reports of untoward incidences are not uncommon. There is also consensus on the fact that only properly trained staff can ensure safety at labs. Use of different types of chemicals, different animal species, radiological materials, different types of gases is quite common in all kinds of labs. As these material are sensitive in nature and lack of knowledge in handling them is asking for trouble.
“Researchers are provided with extensive training for handling animals safely to avoid bites and to minimise experimenter-induced stress in the animals,” points out Pore, who is closely associated with experiments related to animals.
The employees need knowledge of handling safety related emergencies during working in the lab. They are educated by frequent training programmes by safety experts, which includes handling cylinders of compressed gases relevant colour identification codes. Additionally they are educated in the first aid techniques, emergency care and use of antidotes and use of firefighting equipment including fire extinguishers, fire blankets and gas masks.
Though always criticised for safety measures at the labs, according to Chavan, who has extensively worked in an overseas lab environment, India is at par with global standards when it comes to practicing safety. It is done as per the EHS guidelines. In the coming years experiments in labs are going to get more complex. However, on the positive side, technological advances taking place simultaneously are going to fulfill newly generated safety related requirements as well.
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