Pharmaceutical equipment is essential for executing pharmaceutical operations. What is Pharmaceutical equipment, and what types are common in the pharma industry?
Pharmaceutical equipment is used in different processes in the pharmaceutical industry. They help manufacturers in producing drugs of desired qualities and properties. They also help manufacturers ensure a pharma product’s quality and safety.
The pharmaceutical industry cannot produce today’s latest and innovative drugs without using proper equipment. If any manufacturer tries to produce drugs without using proper pharma equipment, the pharma product will lack therapeutic properties. Moreover, regulatory bodies do not allow any manufacturer to start the pharma production without pharmaceutical equipment.
Pharma Equipment is used in all stages of the manufacturing process – from formulation to packing finished pharma products. They are an essential tool for ensuring quality, safety and the required therapeutic effects in the final packaged product.
Requirements for a Pharmaceutical Equipment
Pharma equipment must possess the highest standards of reliability, safety and quality for producing safe and reliable products. Pharma product manufacturers are responsible to incorporate all the necessary and quality features in their equipment.
Essential machine features must be verified when finalizing the machine deal and during the factory acceptance test (FAT) before transporting equipment to the manufacturer’s facility. Otherwise, a regulatory body like the United States FDA will not allow the manufacturer to start its production.
There are many requirements for equipment to qualify for pharmaceutical production, which depend on the product type and manufacturing operation. For particular equipment, it is recommended to consult specific regulatory body guidance.
Some requirements for Pharmaceutical Equipment include, but are not limited to, are listed below.
- The parts that come in direct contact with the product must be made up of SS316 and SS 316L
- The capacity and speed of the machine must match the manufacturer’s requirements.
- Some products, such as antibiotics, require special environmental conditions like Temperature and Humidity. The equipment must safely operate in these specific environmental parameters..
- Adequate safety measures for the product must be incorporated into the machine
- There must be a minimum waste of product and its related material.
- The equipment that uses a software system must include the Audit Trail feature to record the date and time of the person who accessed the computer.
- The surface must be easy to clean and must be free from dead points.
- All piping and fittings must be Orbital Welded.
Types of Pharmaceutical Equipment
In the pharmaceutical industry, there are various processes involved in drug manufacturing. These processes are carried out with the help of different equipment, and the specific process can only be carried out by a specific type of equipment.
Some equipment used in the pharmaceutical industry is indicated below
- Manufacturing Equipment
- Packaging Equipment
- Laboratory Equipment
- Utility Equipment
- Sterilization Equipment
- Filling Equipment
- Washing and Blowing Equipment
Manufacturing equipment is directly involved in pharma product manufacturing. They are used to give pharma products their properties and qualities.
Manufacturing equipment must be operated according to its design parameters to obtain the desired product parameters.
Examples of manufacturing equipment include High Shear Mixer Granulator and Tablet Coating Machine
Packaging equipment are used to pack finished pharma product. Its main purpose is to pack finished products in protective coverings to shield pharma products from various hazardous factors such as environmental and humans.
In packaging equipment, pharma product passes between suitable packaging materials. The packaging material is then sealed with the product in between. In the final stage, the packaged product is cut to its desired dimensions, and packaged product comes out from the machine.
There are three types of Packaging equipment in a pharmaceutical industry.
Primary Packaging Machine
They are used to pack product in packaging material that comes in directly contact with the product. For example, Blister Packing Machines and Ampoule Filling Machine
Secondary Packaging Machine
They are used to pack primary packaged product into group of same products. Examples include cartooning machine
Tertiary Packaging Machine
They are used to pack secondary packed product. Its main purpose is to protect both the product and its packaging during its transportation.
Laboratory equipment are used in laboratory to perform various test on the pharma products. They test different product characteristics, to ensure that the product contains accurate amount of chemical compounds as per claim.
Example of laboratory equipment include Spectrophotometer, HPLC and pH meters
Utility equipment provide various utilities for smooth operation of pharma machinery and other processes in a pharma factory. In most cases, they are installed at places separate from production floor or plant.
Examples of utility equipment include Pharma water systems, Steam Generators, Boilers, Chillers, Air Compressors and Electric generators.
Sterilization equipment is used to sterilize pharma products. They are also used to sterilize various components used in the manufacturing of pharma products, such as tubing, utensils and various stainless steel items.
Sterilization equipment attains the desired temperature and keeps it for a fixed time period. When a specific time elapses, the temperature returns to normal. Once cool, items can be taken out for further usage.
Sterilization temperature and time depend on the product to be sterilized and vary from product to product.
There are two common types of sterilization equipment – Autoclaves and Dry Heat Sterilizers
The autoclave utilizes steam for sterilization. In an autoclave, steam enters the air-tight chamber until the required temperature is achieved with the required pressure. Temperature is maintained through the electronic control system. When required time passes, the autoclave returns to the normal temperature and pressure, and items can be safely unloaded.
Dry Heat Sterilizer
Dry Heat Sterilizer – DHS uses dry heat to achieve sterilization. Hot air blows into the air-tight chamber until the required temperature is achieved. Temperature is controlled through an electronic system.
When the required time has elapsed, the chamber cools down, and items can be safely un-load.
These equipment are used to fill pharma products into the container. The material to be filled is contained inside a hopper. Through filling nozzles, pharma product is transferred inside the container of required fill volume.
Filling volume can be controlled, to prevent volume fluctuation and the container does not contains higher or lower than the required product. Fill volume is controlled automatically, without human involvement.
Examples of filling equipment include Ampoule Filling Machine and Bottle Filling machine
Washing and Blowing Equipment
Washing equipment is used to wash the containers with different fluids, commonly water. Washing is essential before filling to remove dirt or other dust particles. After washing, the container is blown with compressed air to make it dry and remove water content. Examples of washing equipment includes an Ampoule washing machine and a Bottle washing machine.