Hazards related to pharma equipment

In a pharma industry, it is critical to maintain and execute safe machine operation for obvious reasons. It ensures high degree of product safety, safe workplace, and moreover increases the company's reputation. It also enables a pharma company to stand as a reliable, complaint and resourceful entity among its peers

In pharma industry, when hazard occurs, it not only damages the machine or pose danger to personnel working, it also poses danger to the product due to the sensitivity of the product. In this case, the production process has to be repeated again by discarding the product produced. This situation causes financial damage to the pharma manufacturer. Additional damages include loss of infrastructure, equipment and workforce.

Hazards related to pharma equipment

There are different hazards in the pharma industry, but in this article we will focus on hazard related to pharma equipment.

Let's discuss some of these

Moving parts

Moving part is the most common hazard in the pharma industry, due to its mechanical nature. Commonly, moving parts are hidden behind the main structure and are effectively protected. However for some moving parts this cannot be fully isolated  from human interaction. The main reason is that these moving parts require continuous manual adjustment during production process for their operation

These hazard have the following impact

• It can cut off a body part such a finger or toe, and can also slash a human skin

• Movie part can crash with human body resulting in severe damage

• It can damage other machine parts and can result in high maintenance cost and  breakdown

• Loss of product or packaging material

Example of moving parts in an equipment include the following

• Sealing station in blister package machine where a foil is sealed by the action of upper and lower sealing plates.

• Filling machine where are star wheel or turret move bottles from infield, and then to the outfeed, after filling

Over temperature

In pharma industry equipment, temperature has a critical role in the execution of different process, where temperature is required at different processes to achieve desired qualities and properties in a final product.

In some condition the temperature in an equipment becomes uncontrolled, and rises above the set point, and there is no method to stop it. In this scenario, it is a great hazard to man, machine and material and dangerously affects them

When this hazard occurs it can

• Burn the material of contact.

• If liquid is involved it can increase the temperature of liquid and will evaporate it

• It can also cause explosion in the attached machine

• It will change the product characteristics, which will cause it to be discarded

Some example of this hazard can be as follows

• In autoclave, where temperature is required for sterilization in a product container. In this condition, temperature of chamber will increase above its normal threshold limit and will explode the chamber

• In A FBD, specific temperature is required to remove the moisture content in the material. In over-temperature condition the material will over dry and will damage the material properties

Heated parts

Heated parts in pharmaceutical equipment is common where temperature is involved. In this condition, the outer body part can be easily harm the human body.

Example of heated parts consist of

• Blister packaging machine were plates of sealing station remain hot during machine operation

• Outer body of autoclave during and after stabilization process.

Electrical hazard

Electrical hazard it is also the most common hazard in all manufacturing industries including the Pharmaceutical. It's main reason is that all machine requires electrical power to operate, and the system running the electrical power can become dangerous for man, machine and material due to risks associated with the pharma environment. Additionally, for some machine parts it becomes dangerous close to human interaction.

That damage due to electrical hazard can be in vast area and devastating. For some situation its impact can be long lasting, and even everlasting. Additionally, electrical hazard also cause significant damage to electrical installation that can result in long power breakdowns and maintenance activities.

In pharma industry, the risk of electrical has that is heightened due to

• Chemically reactive substances

• Humidity in the production area

• Explosive atmosphere

Due to electrical hazard it can

• It can cause static charge in different equipment specially in granulation suits due to the application of different chemical powders

• Short circuit in electrical panels due to moisture and accumulation of dust

• Fire the area due to interaction of unprotected and exposed electrical circuit or wire in an explosive area.

Over pressure

Pressure in pharma industry is also a common physical variable that is used in different stages of process and equipment. For every part or equipment were pressure is used is critical and can become dangerous in an event of over-pressure.

Over pressure is a condition when the pressure of a fluid becomes uncontrolled and cannot be stop at a specific value. The most common implication of over pressure is explosion in the attached system, equipment or part. Because, the specific part is designed and made to tolerate a specific pressure and cannot tolerate pressure above than the design pressure

Another application is the wastage of fluid which is being used to generate the required pressure. The fluid in pharma industries such as compressed air and nitrogen are costly things, and require additional equipment and consumes resources. Over pressure condition wastes these fluids.

Example of over pressure condition includes the following

• An autoclave uses specific pressure of steam for sterilization and the autoclave chamber is also designed w.r.to sterilization. In case of over pressure condition, the steam will continuously enter into the chamber, more than the design value and can cause the chamber to explode

• In filling operations, containers are purged with Nitrogen gas with a specific pressure, for disinfection purposes. If its pressure becomes uncontrolled, it will waste the Nitrogen, because there is no need to purge Nitrogen with greater than the required pressure.

Safety devices

Let's look at some safety commonly used in Pharma industry

Machine guards

Machine guards are the physical barrier between machine and personal working on it. They protect humans from accidentally coming in contact with moving parts, heated elements, debris of material on machine and contaminants. Additionally their material of construction enables operator or other personnel to have a clear view of machine working without opening them

Commonly, there are two types of guards used in manufacturing machine - Fixed and Interlock

Fixed guards

Fixed machine guards are permanent permanently installed on the machine and cannot be easily removed. Typically they are attached to the machine with screw and bolts, and requires some type of tool to remove from its place. They are typically installed in places which is not required by the operators to physically interact

For example guards installed on a motor are fixed type. Because it only requires physically interaction during maintenance activity, not during the entire production process

Interlock guards

Interlock guards are not fixed type. Instead, they can be opened easily and are fixed with movable clips.. They are interlocked with the machine safety, in a way that if somebody tries to open the guards the machine is stopped with the alarm. The machine cannot be started or operated, until guards are again closed

Example of interlocked are the guards installed on forming foil section of blister packaging machine to adjust foil during production process

Over temperature

Over temperature safety is used to protect a system from over temperature, by different features such as

• Cutting power to the temperature system, so that it could return to normal temperature values

• Complete shutting down of system, until personnel come and physical start the system

• Alarm with sound to alert respective personnel

For over temperature safety, there is a maximum temperature value, that when is exceeded, activates the safety. It is commonly implemented in two ways

• In PLC programming, when the temperature sensor value reaches the certain temperature, it's terminates the process and abort the entire system. it also activates the relevant alert  system

• Additional temperature sensor is installed that continuously monitors the temperature. When it becomes un-controlled, the main controller senses this condition through this, activates the relevant alert system

Over pressure

Over pressure safety is used to prevent our pressure in the attached system. The safety continuously monitors the pressure and stops the system. it also activates an alert when pressure become abnormal.

The over-pressure system safety works in the following way

The pressure monitoring device continually monitors the pressure in the attached system or part. When it reaches the abnormal value, defined by the tolerance of the system or part, the main controller stops the intake of fluid and generates an alarm. The safety cannot be disables or process cannot be re-started, until the pressure returns to normal conditions.

For some machines such as Autoclave and pressure vessel, a manual safety valve is also attached. It immediately releases the excess fluid, casing the pressure of the attached system to noralize. This is a manual system and an effective way of preventing over-pressure condition, in case electronic sensors becomes fail to activate.

About the Author

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.