Table of Contents
The pharmaceutical industry makes use of different equipment at each stage of the manufacturing of drug products. Equipment used may be a single piece such as a weighing machine, or a granulator, or a group of equipment working in a process to deliver a single outcome such as a purified water system.
The ingredients of a formulation come into intimate contact with the equipment at every step. Naturally, the quality of this equipment plays a major role in determining the quality of the final products. Equipment must be designed and constructed in a manner that prevents contamination or any other adverse impact on the drug material.
Design and Construction:
Equipment must be designed and constructed to suit the purpose of its use. The material of construction must be adequate to the nature of processing to be undertaken. Equipment surfaces that come into contact with drug products must not be additive, reactive, or absorptive. If the surface of equipment adds chemicals from its surface into the drug material, or reacts with it, or absorbs the formulation ingredients, there can be a serious impact on the identity, safety, strength, purity, and quality of the final product.
Equipment must be designed for closed operation as far as possible to reduce the risk of contamination of material it holds. If open equipment is unavoidable, it must be designed and handled in a way that minimizes contamination. Diagrams of critical equipment must be maintained. Lubricants used in equipment maintenance should be of non-toxic or edible grade. Such lubricants or coolants used on the equipment must not come into contact with the drug product, its containers, or closures. Failure to ensure this will contaminate the drug and render it unsafe for use.
Equipment must be located in a clean, hygienic area that is suitable for the operation being performed. When several types of equipment are to be used as part of a process, they must be located in such a way as to allow the linear and sequential flow of the production process. The equipment must be situated in a way that allows ease of cleaning and maintenance.
Equipment must be installed in keeping with the manufacturer’s specifications. All necessary utilities must be provided and there must be arrangements to access the equipment for maintenance work without having to enter the production areas. Pipework leading to and from any equipment must be labeled with contents and direction of flow. Any defective equipment must be removed to a separate area outside the production or quality control area. In case this is not possible, the equipment must bear a conspicuous label that states its defective status.
Cleaning and Maintenance
Written procedures must exist for the cleaning of equipment and their regular maintenance. Cleaning must be done at regular intervals to avoid the entry of contaminants; equipment must also be cleaned thoroughly between different batches of product to avoid the risk of cross-contamination. For equipment used in manufacturing sterile products, additional steps need to be taken to sanitize and sterilize the equipment to maintain it in a sterile condition. Regular maintenance must be performed for all critical equipment to ensure there are no malfunctions during a processing run. Cleaning validation studies must be performed to ensure equipment cleaning leads to the desired levels of cleanliness.
Qualification and Calibration
Qualification of equipment begins right at the design stage when it is designed to be constructed in a particular manner suitable to its intended purpose. Steps of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) must be carried out to ensure the equipment is designed, installed, operated, and performed as expected to give a quality product.
Once the equipment has become operational, with wear and tear over time, there is a chance of drift in its performance from expected profiles. So, it is vital to have a regular calibration program in which the equipment and any associated instruments are checked to obtain a measure of how accurately it is performing. These calibration results can help to identify defects in the equipment, which can then be dealt with appropriately.
Records of calibration and qualification must be maintained for all equipment.
When a computer or related systems are used, there must be sufficient control to ensure that any changes in records take place only after due authorization by higher management. Backup files of data must be maintained and stored in a way that is protected from alteration or loss. Hard copies of backup data must be maintained, too.
All the major equipments should have a unique identification code or number, and this must be recorded in the batch manufacturing record (BMR). Separate cleaning and maintenance logs must be maintained for each of the major equipment, and any cleaning or maintenance activity must be recorded in these. Standard operating procedures must exist for operating all equipment, and they must be placed close to the equipment for use by the personnel handling them.
The major equipment being used in manufacturing a given batch must be labeled with details of product name and batch number at all times to indicate the contents within.
Purchase Specifications for Equipment
Pharmaceutical industry equipment is quite expensive and therefore, selecting the right equipment is a critical process. Some of the most important factors to be considered in making this decision are as follows:
- Desired output capacity: Equipment purchased must be capable of processing desired quantity of product at the desired speed of operation. Understanding one’s production scale in terms of batch size requirements and comparing this with the load capacity of the equipment being considered is an important first step when choosing equipment.
- Product characteristics: The nature of the product, its reactivity, any special conditions necessary to ensure retention of its safety, efficacy, and quality are all important while choosing equipment.
- Ease of operation: Equipment operation must be simple, and not involve complex maneuvers or require special skills. The equipment must be easy for the operator to operate after receiving proper training. It is important to strike a balance between the efficiency of performing the given operation and ease of operating the equipment. Digitally enabled equipment can help to manage the manufacturing process better; it will however require special skills for operation and the capacity of one’s workforce to learn those skills must be considered.
- Ease of cleaning and maintenance: Equipment will require regular cleaning and special, more thorough cleaning between batches of different products. The time used for cleaning is time lost from the production run. So equipment must be easy to clean (either in-place or by disconnecting and taking to a special cleaning area). It must also be easy to maintain and not require frequent maintenance activities which again are a time-consuming process.
- Equipment supplier: When buying equipment, price is often considered an important criterion, but it is more important to focus on the quality parameters on offer and the industry reputation of the supplier and how reliable their product is, their customer service, and their capability to provide equipment troubleshooting service when necessary.
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