Pharmaceutical manufacturers employ several types of equipment at each stage of the drug manufacturing process. Examples of the equipment often used in this field include single pieces such as weighing machines or an equipment group that has all its parts working together in a process to deliver a high-quality single outcome.
The materials that make up the equipment must be designed to not only suit the intended purpose, but also be constructed in a way that does not add, absorb, or react with the pharmaceutical components. This is because any addition or subtraction of materials can have serious consequences on the pharmaceutical ingredient’s safety, strength, and quality.
Equipment Design and Location
The qualification of equipment begins with the design phase. Here, the equipment is specifically designed and constructed in a manner that is suitable for its intended purpose. The qualification steps include:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
These four design steps help ensure the equipment is produced at a high-caliber level and is fit to carry out its functions properly.
Once the equipment is operational, it is vital to have a regularly scheduled calibration program. This allows you to take a measure of how accurately your machines are performing. Calibrations allow you to identify if there are any defects present in the equipment. With early detection, severe consequences and downtime can be minimized and avoided. It is imperative to keep a running record of all calibration activities and their results.
Not only must the equipment be made from safe materials, but you must also factor in the location of the equipment and ensure it exists in a clean area suitable for the operations. If multiple pieces of equipment are needed for the final product, they must be aligned in such a way as to allow for easy cleaning and maintenance all without disrupting the production process. All the pipework connected to the equipment must also be properly labeled to show the contents and the direction of the flow. If there is any defective equipment, it must be removed to a separate area, away from the other machinery parts, to ensure quality control.
When it comes to maintaining the equipment, it’s important to have specialized procedures in place. To avoid contamination, the equipment must also be thoroughly cleaned before a new batch can be produced. Knowing when to perform maintenance is best determined by monitoring the condition of your equipment.
Condition monitoring techniques include:
- Vibration – Vibration analysis is an excellent tool for detecting problems early in the cycle. It allows for the detection of a wide range of mechanical and electrical problems within rotating machinery and its components, such as bearings and gears. This combined with oil analysis can give you a clear picture of the inner workings of your equipment.
- Thermography – Thermography’s real value comes not from instantaneous results, but from the trending of data. It can be used to quickly obtain a multi-point temperature profile that a trained individual can easily assess. This type of inspection can be performed with relatively little disruption to the machine’s operations.
- Ultrasound Technology – Ultrasound technology is a great fit for condition-based lubrication methods. Ultrasonic equipment detects both airborne and structure-borne ultrasonic waves that would normally be inaudible to the human ear. Then the technology transposes these noises into audible signals that a technician can hear through headphones or see on a decibel display panel. One piece of ultrasound tech that goes above and beyond is the OnTrak system, which will remotely and accurately lubricate your bearings on critical equipment when friction is detected. Instead of living in a reactive maintenance state, the automated system focuses on being proactive and catching failures before they happen.
Your major equipment should also have a unique identification number which must be recorded. Each major piece of equipment should also have its own cleaning and maintenance logs that should be updated any time cleaning or maintenance activities are performed. There must also be a standard operating procedure for each piece of equipment that is kept within close proximity to the machine. For major pieces of equipment used in manufacturing a given batch, each batch must be labeled with the product details and batch number to indicate what the contents of the batch are.
Pharmaceutical industry equipment can come with a steep price tag, so selecting the right equipment for your site is a critical component. Some important factors to consider when selecting a piece of equipment include:
- Desired Output Capacity: The equipment must be able to process the desired quantity of product at the desired manufacturing speed while also being able to produce at scale in terms of batch size requirements.
- Product Characteristics: This includes any special conditions that should be noted to ensure safety, efficiency, and quality standards are being met.
- Ease of Operation: With the proper training, the equipment should be easy to operate. There should always be a balance of performance efficiency and ease of use.
- Easy Cleaning and Maintenance: Pharmaceutical equipment will require regular cleaning, especially in between batches. Time spent on cleaning and maintenance activities is time lost, so it is important that the equipment is easy to clean and maintain.
- Equipment Supplier: When buying equipment, while the price is an important factor, it’s not the only factor. It is more important to focus on the quality of the equipment as well as the reputation of the supplier in the industry. This will tell you how reliable the product is, how helpful their customer service team is, and their ability to provide troubleshooting services if ever necessary.
Pharmaceutical manufacturers must take several factors into consideration simultaneously when attempting to streamline their processes and grow their bottom line. If these factors are not taken seriously, they can cause severe damage to the machine and can cause batches to become contaminated. With the help of proper planning and the use of advancing technologies, such as UE System’s OnTrak system, a balance can be found and the quality of production can be guaranteed at all levels.