Clean steam systems in the Pharmaceutical Industry

What is clean steam?

Clean steam is used in the pharmaceutical and healthcare industries in processes where the steam or its condensate can come into contact with a pharmaceutical or medical product and cause contamination. In such cases, steam from a conventional boiler(often called utility or plant steam)is unsuitable because it may contain boiler additives, rust or other undesirable materials.+

The use of clean steam is determined by the rules of Good Manufacturing Practice (GMP). These are general rules applicable to pharmaceutical manufacture,detailed in the Code of Federal Regulations(CFR Title 21,Part 211). They do not provide any specific recommendations regarding steam, but do present the general requirements offacilities, systems, equipment and operation needed to prevent contamination of pharmaceutical products during their manufacture.

Uses of clean steam:

The main use of clean steaming pharmaceutical manufacturing is for the sterilization of products or, more usually, equipment. Steam sterilization is encountered in the following processes:

  • Manufacture of injectable or parenteral solutions, which are always sterile.
  • Bio-pharmaceutical manufacturing, where a sterile environment must be created to grow the biological production organism(bacterium, yeast or animal cell).
  • Manufacture of sterile solutions,such as ophthalmic products.

Typically in these processes, clean steam is injected into equipmentor piping to create a sterile environment, or into autoclaves where loose equipment, components (such as vials and ampoules)or products are sterilized.

Clean steam may be used for some other functions where conventional utility steam might cause contamination, such as:

  • Humidification in some clean rooms.
  • Injection into high purity water for heating prior to Clean-in-Place (CIP) operations.

Fundamentals of clean steam system design:

Avoidance of corrosion

Unlike utility steam, clean steam has no corrosion inhibitors. Also, low conductivity water or condensate is hungry for ions, causing it to be corrosive to many materials commonly used in utility steam systems. Carbon steel,gunmetal and bronze, all commonly found in utility steam components, would all be rapidly corroded. Metal components for clean steam systems are therefore usually AISI 316 L stainless steel, or sometimes titanium. Non-metallic materials used include EPDM and PTFE.

Then eed to avoid corrosion is not only necessary for safeguarding the integrity of equipment. Corrosion products entering the clean steam could potentially cause contamination of the pharmaceutical product, either as chemical or particulate contamination.

Even where 316l stainless steel is used, a particular form of corrosion, called “rouging”, is often encountered in clean steam systems. The passive layer on the steel surface is disrupted and a red/brown/black film develops over time. Often this film is stable and does not pose a threat to the pharmaceutical product. Sometimes a powdery film develops and this can detach from the steel surface and cause discoloration of equipment which the steam contacts.
If this occurs, and the manufacturer feels that there is a risk of contamination or discoloration of the product, then the clean steam generator or even the full distribution system may be cleaned (“derouging”).

A variety of methods are used, but they all involve a chemical treatment to remove the surface layer of steel – this is essentially an etching process. After de-rouging, a passivation process must be used to restore the passive layer on the steel surface, since it is the passive layer that is responsible for corrosion resistance.

Preventing entry of contaminants into the system

Clean steam must be free of contaminants at the point of use. Chemical and microbial contaminants can enter steam systems in a variety of ways, and in the design of clean steam systems this must be avoided. Pathways for contamination include leakage, air being pulled into the system and “grow through” from a contaminated external environment.

Preventing microbial growth in the system

Steam at typical operating pressures will kill bacteria and their spores, so the parts of a clean system that are continuously exposed to steam will be sterile. However, if condensate is allowed to collect in the system, and it cools, then stagnant water can provide a suitable environment for bacterial growth. Though these bacteria may be killed when the condensate is discharged into equipment, followed by steam, their breakdown products, including endo toxins, may still be present. Endo toxins are not destroyed by typical clean steam system temperatures.

Looking for a clean steam system design consultant? Look no more, contact Panorama now!

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.