Design For Safety Equipment and design

Design for safety

System safety

System Safety is the application of engineering and management principles, criteria, and techniques to optimize all aspects of safety within the constraints of operational effectiveness, time, and cost throughout all phases of the system life cycle. It is a planned, disciplined and systematic approach to preventing or reducing accidents throughout the lifecycle of a system

Primary concern is the management of risks through:

  • Risk identification, evaluation, elimination & control through analysis, design & management

History of system safety

Design Safety arose in the 1950s after dissatisfaction with the fly-fix-fly approach to safety. Design Safety was first adopted by the US Air Force. It led to the development of mil-std-882 Standard Practice for System Safety (v1 1960s). The basic concept of System was rather than assigning a safety engineer to demonstrate that a design is safe, safety considerations were to be integrated from the design phase of the project.

Founding principles

Safety should be designed in

  • Critical reviews of the system design identify hazards that can be controlled by modifying the design
  • Modifications are most readily accepted during the early stages of design, development, and test
  • Previous design deficiencies can be corrected to prevent their recurrence

Inherent safety requires both engineering and management techniques to control the hazards of a system

  • A safety program must be planned and implemented such that safety analyses are integrated with other factors that impact management decisions

Safety requirements must be consistent with other program or design requirements

  • The evolution of a system design is a series of tradeoffs among competing disciplines to optimize relative contributions
  • Safety competes with other disciplines; it does not override them

The main principles of Safe design are:

  • Inherent safety
  • Safety factors
  • Multiple independent safety barriers

Inherently safe design 

Inherent: belonging to the very nature of the person/thing (inseparable). It is recommended that Inherent safe design should be the first step in safety engineering. Change the process to eliminate hazards, rather than accepting the hazards and developing add-on features to control them, unlike engineered features, inherent safety cannot be compromised.

Minimize inherent dangers as far as possible by considering the following:

  • Potential hazards are excluded rather than just enclosed or managed
  • Replace dangerous substances or reactions by less dangerous ones (instead of encapsulating the process)
  • Use fireproof materials instead of flammable ones (better than using flammable materials but keeping temperatures low)
  • Perform reactions at low temperatures & pressures instead of building resistant vessels

Safety Factors

Factors of safety (FoS), also known as safety factor (SF), is a term describing the load carrying capacity of a system beyond the expected or actual loads. Essentially, the factor of safety is how much stronger the system is than it usually needs to be for an intended load. Safety factors are often calculated using detailed analysis because comprehensive testing is impractical on many projects, such as bridges and buildings, but the structure’s ability to carry load must be determined to a reasonable accuracy.

When the material used is under strength, factor of safety covers uncertainties in material strength. It covers poor workmanship. It also covers unexpected behavior of the structure and natural disasters. Stresses are produced which may be very high. Factor of safety may take care of these loads during construction. Presence of residual stresses and stress concentrations beyond the level theoretically expected.

Multiple Independent Safety Barriers

Safety barriers are arranged in chains. The aim is to make each barrier independent of its predecessors so that if the first fails, then the second is still intact, etc. Typically, the first barriers are measures to prevent an accident, after which follow barriers that limit the consequences of an accident, and, finally, rescue services as the last resort.

The basic idea behind multiple barriers is that even if the first barrier is well constructed, it may fail, due to unforeseen reason, and that the second barrier should then provide protection. The major problem in the construction of safety barriers is how to make them as independent of each other as possible. If two or more barriers are sensitive to the same type of impact, then one and the same destructive force can get rid of all of them in one swoop.

These three principles of engineering safety – inherent safety, safety factors, and multiple barriers are quite different in nature, but they have one important trait in common. They all aim at protecting us not only against risks that can be assigned meaningful probability estimates, but also against dangers that cannot be probabilized, such as the possibility that some unforeseen even triggers a hazard that is seemingly under control. It remains, however, to investigate more in detail the principles underlying safety engineering and, not least, to clarify how they relate to other principles of engineering design.

 

 

Cleanroom

Typically used in manufacturing or scientific research, a cleanroom is a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. To be exact, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. The ambient air outside in a typical city environment contains 35,000,000 particles per cubic meter, 0.5 mm and larger in diameter, corresponding to an ISO 9 cleanroom which is at the lowest level of cleanroom standards.

Cleanroom Overview

Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process. They vary in size and complexity, and are used extensively in industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical device and life sciences, as well as critical process manufacturing common in aerospace, optics, military and Department of Energy.

A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary; Ultra Low Particulate Air (ULPA) filters are used.

Personnel selected to work in cleanrooms undergo extensive training in contamination control theory. They enter and exit the cleanroom through airlocks, air showers and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body.

Depending on the room classification or function, personnel gowning may be as limited as lab coats and hairnets, or as extensive as fully enveloped in multiple layered bunny suits with self-contained breathing apparatus.
Cleanroom clothing is used to prevent substances from being released off the wearer’s body and contaminating the environment. The cleanroom clothing itself must not release particles or fibers to prevent contamination of the environment by personnel. This type of personnel contamination can degrade product performance in the semiconductor and pharmaceutical industries and it can cause cross-infection between medical staff and patients in the healthcare industry for example.

Cleanroom garments include boots, shoes, aprons, beard covers, bouffant caps, coveralls, face masks, frocks/lab coats, gowns, glove and finger cots, hairnets, hoods, sleeves and shoe covers. The type of cleanroom garments used should reflect the cleanroom and product specifications. Low-level cleanrooms may only require special shoes having completely smooth soles that do not track in dust or dirt. However, shoe bottoms must not create slipping hazards since safety always takes precedence. A cleanroom suit is usually required for entering a cleanroom. Class 10,000 cleanrooms may use simple smocks, head covers, and booties. For Class 10 cleanrooms, careful gown wearing procedures with a zipped cover all, boots, gloves and complete respirator enclosure are required.

Cleanroom Air Flow Principles

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream. Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-4 classified cleanrooms.

Proper cleanroom design encompasses the entire air distribution system, including provisions for adequate, downstream air returns. In vertical flow rooms, this means the use of low wall air returns around the perimeter of the zone. In horizontal flow applications, it requires the use of air returns at the downstream boundary of the process. The use of ceiling mounted air returns is contradictory to proper cleanroom system design.

Creating a Project Safety Plan

Any project that is within the fields of engineering or construction will come a high level of risk. It is possible to keep this risk low and prevent any serious accident occurring, however in order to do this you need to ensure that the safety plan you put in place is up to scratch. You need to tailor everything to your specific project and have a constant line of communication with team members regarding safety.

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Utility System Qualification for the Pharmaceutical Industry

Pharmaceutical equipment manufacturing is a highly regulated industry. Given the stress on product quality and the widespread impact of substandard production on public health and safety, utility system qualification is a critical step that companies must take towards ensuring that all their products comply with federal laws and regulations.

In pharmaceuticals, critical utilities like water and HVAC (Heating, Ventilation and Air Conditioning) systems form the backbone of the manufacturing process. As a result, these are treated, as products that need to satisfy FDA regulatory requirements and pharmaceutical manufacturing standards, just like raw materials and other equipment used in the industry.

The primary use of a utility system is to help pharmaceutical companies check the quality and safety of their products and to ensure they comply with the laws and statutes in the FDA dossier. Without meeting these requirements, a product may fail to be cleared for marketing.

To pass inspection, utilities must pass a string of qualitative and quantitative specifications. Different utility systems have different quality and standard criteria, designed on the basis of inputs from relevant departments and organizations as well as manufacturing and engineering provisions.

When a validation program is set in place for utility systems used in pharmaceutical, critical utilities should be first on the list. It’s important to focus on the design, qualification and monitoring of each utility system used in pharmaceutical or biotech companies, so their end product fulfills all pharmaceutical quality standards.

Utility system qualification is designed to ensure that utilities in use conform to health and safety regulations, as well as pharmaceutical manufacturing standards and cGMP guidelines.

Current good manufacturing practices (cGMPs) are FDA guidelines that check the design, control and monitoring of manufacturing facilities and processes. To comply with cGMP regulations, drugs and medicinal products need to be of the right quality, strength and purity, by way of adequately controlled and monitored manufacturing operations.

Steps in utility system qualification include implementing strong operating procedures, establishing extensive quality control systems, procuring a consistent quality of raw material supplies and maintaining dependable testing labs.

If such a broad control system is implemented in a pharmaceutical facility, it can help to control instances of mix-ups, contamination, errors, defects and deviations during the manufacturing process. Such pharmaceutical products are better able to meet public health and safety laws established by the FDA.

Pharmaceutical cGMP guidelines are flexible enough that all manufacturers are free to decide how to apply FDA controls in ways that fits their unique requirements. They can make use of a variety of processing methods, testing procedures and scientific designs to adapt their manufacturing processes to meet the laws.

Because of the flexibility of these laws, companies can use innovative approaches and sophisticated technology to implement a system of continual improvement in order to achievement a consistent quality of pharmaceutical supplies.

All pharmaceutical manufacturing facilities need to adhere strictly to FDA-approved regulations. There is a lot of stress on the compliance of facility design with cGMP regulations as well as the various procedures associated with pharmaceutical production, so drugs are manufactured under conditions that meet FDA approval.

Failure to meet FDA regulations can result in responsive action by the authorities against the product or the responsible facility, depending upon the seriousness of non-compliance. The company may have to recall the product under orders of the FDA, to ensure it does not cause additional harm or risk to the public.

cGMP requirements can be useful in ensuring the efficacy, quality and safety of pharmaceutical products by making sure facilities are in good operating condition, with sufficiently calibrated and well-maintained equipment, trained and experienced staff and reliable and efficient processes.

While a utility system cannot affect product quality on its own, it forms an integral part of the manufacturing process. Panorama helps you set up validation processes as per your needs.

Validation

Validation Protocols for Pharmaceutical Industries

For pharmaceutical industries, product quality is paramount. Minor inconsistencies can lead to major disasters. To maintain quality assurance, consistency and risk assessment, industries conduct a validation of processes and equipment. A validation is a documented evidence of the consistency of processes and equipment. Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) are an essential part of quality assurance through equipment validation.

DQ IQ OQ PQ protocols are ways of establishing that the equipment which is being used or installed will offer a high degree of quality assurance, so that manufacturing processes will consistently produce products that meet predetermined quality requirements.

Design Qualification (DQ)

Design qualification is a verification process on the design to meet particular requirements relating to the quality of manufacturing and pharmaceutical practices. It is important to take these procedures into consideration and follow them keenly. Along with Process Validation, pharmaceutical manufacturers must conduct Design Qualification during the initial stages. For DQ to be considered whole, other qualifications i.e. IQ, OQ and PQ need to be implemented on each instrument and the system as a whole.

DQ allows manufacturers to make corrections and changes reducing costs and avoiding delays. Changes made to a DQ should be documented which makes DQ on the finalized design easier and less prone to errors. By the use of a design validation protocol it is possible to determine whether the equipment or product will deliver its full functionality and conform to the requirements of the validation master plan.

Installation Qualification (IQ)

Any new equipment is first validated to check if it is capable of producing the desired results through Design Qualification, but its performance in a real-world scenario depends on the installation procedure that follows. Installation Qualification (IQ) verifies that the instrument or equipment being qualified, as well as its sub-systems and any ancillary systems, have been delivered, installed and configured in accordance with the manufacturer’s specifications or installation checklist. All procedures to do with maintenance, cleaning and calibration are drawn at the installation stage. It also details a list of all the continued Good Manufacturing Procedures (cGMP) requirements that are applicable in the installation qualification.

Conformance with cGMP’s requires, that whatever approach is used, it is fully documented in the individual Validation Plan. The IQ should not start with the Factory Acceptance Testing (FAT) or Commissioning tasks, but it should start before these tasks are completed; enabling the validation team to witness and document the final FAT and commissioning testing. The integration of these activities greatly reduces the costly and time consuming replication of unnecessary retesting.

These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of the OQ.

Operational Qualification (OQ)

Operational Qualification is an essential process during the development of equipment required in the pharmaceutical industry. OQ is a series of tests which of tests which ensure the equipment and its sub-systems will operate within their specified limits consistently and dependably. Equipment may also be tested during OQ for qualities such as using an expected and acceptable amount of power or maintaining a certain temperature for a predetermined period of time. OQ follows a specific procedure to maintain thoroughness of the tests and accuracy of the results. The protocol must be detailed and easily replicated so that equipment can be tested multiple times using different testers. This ensures that the results are reliable and do not vary from tester to tester. OQ is an important step to develop safe and effective equipment.

Performance Qualification (PQ)

PQ is the final step in qualification processes for equipment, and this step involves verifying and documenting that the equipment is working reproducibly within a specified working range. Rather than testing each instrument individually, they are all tested together as part of a partial or overall process. Before the qualification begins, a detailed test plan is created, based on the process description.

Process Performance Qualification (PPQ) protocol is a vital part of process validation and qualification, which is used to ensure ongoing product quality by documenting performance over a period of time for a certain process.

Equipment qualification through DQ IQ OQ PQ practices is a part of Good Manufacturing Practice (GMP), through which manufacturers and laboratories can ensure that their equipment delivers consistent quality. It reduces the margin for errors, so the product quality can be maintained within industry standards or regulatory authority requirements. When qualification of equipment is not needed very frequently, performing it in-house might not be feasible, so smaller laboratories might benefit from scheduling external equipment validation services on a regular basis instead.

Temperature Mapping for Pharmaceutical Industry

Temperature mapping is important for verifying the efficacy of temperature controlled storage systems such as cool rooms, fridges and warehouses. It is vital for businesses that work with temperature sensitive products such as pharmaceuticals or warehouses.

The process of mapping outlines the differences and changes in temperature that occur within a single temperature controlled system. This is due to influences like opening doors, proximity to cooling fans, personnel movement, and the quantity of products being stored at any given time. Temperature mapping locates the points of greatest temperature fluctuation and difference then analyses the causes of these. Conditions are created to verify that a system maintains the correct temperature in all situations when influenced by external factors such as weather and internal factors such as airflow restrictions and the operation of the Heating, Ventilation and Air Conditioning systems. The effects in difference of temperature are calculated to ensure the systems meet industry standards.

The temperature of different spaces within cooling rooms, industrial fridges and other controlled temperature environments can vary by up to 10°C. Generally, the central space within a chamber maintains constant temperature, however the corners and areas surrounding the fans will fluctuate. External seasonal weather must also be taken into account especially for warehouses.

Temperature mapping is important for businesses and organisations dealing with temperature sensitive products, like biochemical products such as medications and vaccines. Verifying that the refrigeration systems maintain an acceptable temperature level for each specific product at all times is what temperature mapping is all about, and this is supported using ongoing monitoring systems.

Once mapping has established where temperature variation points lie within the control system then monitoring can be installed. It is important to re check any back up systems to be sure that the chambers will work in other circumstances.

Different mapping equipment gives different results. It is important to ensure that the equipment being used has sufficient accuracy ratings to give reliable data. For example, better equipment will provide readings that are accurate within plus or minus 0.3°C, whereas budget equipment may only have accuracy ratings of within 2.0°C. For products that must be stored within a limited temperature range, this budget equipment cannot provide sufficiently specific temperature data.

Warehouses must have information regarding the building’s external conditions, as it is vital for effective mapping and monitoring. Warehouses are generally mapped for a full year to ensure all external conditions are accounted for in the data. This also helps to determine placement of monitoring systems due to influence of external conditions.

Temperature-controlled rooms such as fridges or cold rooms can be mapped once as their external environment is controlled. However, it is advisable to make sure that other external forces that could change their temperatures significantly do not heavily influence the HVAC systems of these buildings or environments. The mapping in warehouses should take into account the fluctuation in the warehouse temperatures and conduct the tests during its most extreme levels.

Load testing is important aspect of the temperature mapping process. It investigates how expected product levels interact with individual temperature controlled chambers. This testing takes into account whether the product will arrive in the required condition or if cooling is necessary. Testing should verify whether the chamber could cope with the maximum specified load arriving all at once to then be cooled. If it can operate properly in this situation, as well as operating effectively at full capacity, the chamber can be considered sufficiently load tested. It is also advisable to test the system’s performance by simulating failures, to ascertain whether the system could be used even while experiencing some equipment failures.

Once the mapping process has been completed, sensors should be installed to allow for continued surveillance of the areas that have been identified as being most influenced by temperature change. The stable areas should be monitored to help with any troubleshooting.

Monitoring systems should be planned and documented according to the scientific rationales shown by the temperature mapping procedure. This development strategy should then be reviewed and approved by the system owners as well as by an independent quality unit before being installed. Sensors should be placed around the products, around major potential temperature influences such as doors and cooling fans, and at different heights, especially in larger chambers.

Sensor equipment can be split into zones according to the area affected by similar influences. For example, in a square or rectangular chamber, the zones in corners away from doors will behave much the same as each other, as will the zones adjacent to doors or fans. If the monitoring devices are zoned, data can be compared to provide overall information on how the system usually functions.

To summarize, temperature mapping provides information on warmer and colder areas within temperature-controlled environments. They supply details on the overall operation of the systems. After temperature mapping a system, monitoring equipment can be installed to provide real-time feedback on system operations and its stability for product protection.

Fire Protection and Safety

Irrespective of its occupancy status, a fire can happen at any time and any place.
Fire has the potential to cause harm to its occupants and severe damage to property. Fire doesn’t only interrupt the whole process of manufacturing and production but also can cause major damage to the building and plant. Much work will be required in order to restore the entire production process.

Successful prevention of fire depends solely on the management who must survey the operation of the business and determine where the loss potential lies.

Inadequately maintained machines can be fire prone. The overheating of bearing, due to insufficient lubrication or the presence of dust, and heat caused by friction are common causes of fire. Frequent inspection and regular maintenance will reduce risk and make the general tidiness of premises easier to achieve.

Major fires start in storage area and warehouses than production areas. Poorly stored goods, even though they are not flammable, may help to spread fire and hinder fire fighters gaining access to the seat of the fire or reduce the effectiveness of sprinkler systems. Goods tidily stored with gangways may help to inhibit the spread of fire.

Fire Safety Audit

Fire has been rated as the 5th largest risk in the Indian Industry. Electrical defaults are the major causes of fire in India. Fire Safety Audit is found to be an effective tool for assessing fire Safety standards of an organization. In other words, it is aimed to assess the building for compliance with the National Building Code of India, relevant Indian Standards and the legislations enacted by State Governments and Local Bodies, on fire prevention, fire protection and life safety measures.

Though fire safety audit is found to be an effective tool for assessing fire safety standards of an occupancy, there is no clear cut provisions in any of the safety legislations in India, regarding the scope, objective, methodology and periodicity of a fire safety audit. Therefore, Fire Safety Audit should be made mandatory for all over India and the work should be entrusted to independent agencies, which have expertise in it. It is reasonable to have a fire safety audit in every year.

Clean agent suppression systems

Clean agent fire suppression systems make the use of inert gases and chemicals in extinguishing a fire.They are also known as gaseous fire suppression. In these systems, fire is suppressed manually or automatically by reducing heat rather than reducing oxygen, reducing fuel or preventing the chain reaction effect of fire. These systems work on a total flooding principle where the agent is applied in a three dimensional method within the enclosed space to deliver a concentrated, highly focused dose of fire suppression.

Clean agent systems are able to suppress fires without causing additional damage unlike water. This drastically reduces the costs incurred for repairs and replacements. This makes these systems the fire suppression systems of choice for commercial and public enterprises that want fast, effective fire suppression that minimizes damage to structures, electronics and other assets.

The agents are non-toxic, they cause no breathing problems for people and won’t obscure vision in an emergency situation.

Automatic Sprinkler Systems

Sprinkler systems are among the most useful tools in firefighting. Automatic sprinklers often are one of the most important fire protection options. The successful application of sprinklers is dependent upon careful design and installation of high quality components by capable engineers and contractors.

A sprinkler system must be installed in compliance with the building’s need. Wet pipe systems offer the greatest degree of reliability and are the most appropriate system type for most heritage fire risks. With the exception of spaces subject to freezing conditions, dry pipe systems do not offer advantages over wet pipe systems in heritage buildings. Preaction sprinkler systems are beneficial in areas of highest water sensitivity. Their success is dependent upon selection of proper suppression and detection components and management’s commitment to properly maintain systems. Water mist represents a very promising alternative to gaseous agent systems.

In India, although there are many rules and regulations, codes and standards related to fire safety they are seldom followed. Laxity in following fire safety measures causes major fires in many buildings. Proper attention must be paid to minimize fire loss because ultimately the community at large has to bear all the losses. There exists large number of different types of firefighting equipment and suppression systems to suit specific requirements. The use of smoke detectors, fire alarms, automatic sprinklers, water mist systems, clean agent suppression system should be encouraged. Above all the success of fire prevention and fire protection mainly depend upon the active co-operation from all personnel.