Design of machines and equipment used in pharmaceutical industries need special attention which are not normally considered in other industries. For example, finish quality of a machined surface of reactor is very important in pharmaceutical industry to avoid material accumulation and contamination. Similarly, packaging of drugs and medicines is one of the most important operations in pharmaceutical industry, which need special care during their design and fabrication. Some machineries and equipment are exclusively used in pharmaceutical industry, e.g., capsule filling machine which may be of semi-automatic as well as automatic type. Safety and reliability are also a major concern, in design of machines and equipment used in pharmaceutical industry.
First of all, all the machines and equipment used in the pharmaceutical industry are needed to be validated in accordance with current good manufacturing practices (cGMPs). The resulting data are subject to examination by field investigators during routine GMP inspections. This article discusses the special features of machines and equipment that required for their use in pharmaceutical industry.
Medicines are manufactured in different forms viz., capsules, tablets, pills, drugs, and many more. To manufacture these different forms of medicine we need different processes and different types of machines and equipment are used. Although the number of individual processes used in pharmaceutical industry is great, each one can be broken down into a series of steps, called operations, each of which in turn appears in process after process.
The individual operations have common techniques and are based on the same scientific principles. For example, in most processes solids and fluids must be moved; heat or other forms of energy must be transferred from one substance to another; and tasks like drying, size reduction, distillation, and evaporation must be performed. The unit-operation concept is this: by studying systematically these operations themselves-operations that clearly cross industry and process lines-the treatment of all processes is unified and simplified. In most pharmaceutical industries, the unit operations followed may be categorised in to following 11 unit operations.
- Particle size reduction, classification/separation,
- Blending and mixing,
- Emulsification,
- Deaeration,
- Transfer (of liquid and solid),
- Drying
- Granulation
- Unit dosing (tabletting, encapsulating, powder filling)
- Coating and printing
- Soft gelatin capsule encapsulation and
- Packaging.
To perform above unit operations, different machineries and equipment are used in pharmaceutical industry. In pharmaceutical industry, machineries are used mainly for tableting, tube filling, liquid filling and labelling. With the growth of pharmaceutical companies, machine manufacturers are also upgrading themselves to meet the challenges arising out of the requirements set by the pharmaceutical industry. Most of the leaders in the field are looking towards advanced market for their machinery. As these countries mandate proper validation of the products, the importance of machineries which incorporate advanced technologies and standards are also increasing.
Equipment are categorized according to class (based on operating principle) and subclass (on the basis of design characterization). For example, for mixing and blending different sub-class equipment viz., v-blenders, double cone blenders, slant cone blenders, cube blenders, bin blenders, horizontal/vertical/drum blenders, static continuous blenders and dynamic continuous blenders are used. Change in equipment to a different design or different operating principles. Change in type of mixing equipment, such as high shear to low shear and vice versa.
The equipment of good design only are considered in pharmaceutical industry and all the equipment are maintained properly. There should be a correct choice of cleaning equipment.
Fluid bed dryer: Dry powder medicines are prepared by using advanced drying process. Fluid bed dryers are commonly used in pharmaceutical industry for this purpose. This machine helps to prepare the medicine to make it dry powder forms completely. Fluid bed dryers are utilized in sectors wherein cooling as well as drying are needed areas of production. This consists of food items, sand, medications, nutrients, along with a variety of additional industries. Fluid beds can be utilized for working of the majority of kinds of powdered items. Fluid bed procedures consist of drying, agglomeration, spray coating, cooling, deducting and also in-situ lecithination. Anchormark.com provides batch and also continuing fluid beds, along with fluid beds to be built-in into multi-stage spray drying plant life.
Tablet compression machine: Tablet compression machine is an essential device for tablet or solid dosage formulation process. These machines are widely used to press granular or powder material to produce tablets of homogeneous size and weight. High-speed and long lasting tablet compression machines are available for demanding applications not only for the pharmaceutical industry, but for other industries too.
Scale-up: The scale-up process and the changes made after approval in the composition, manufacturing process, manufacturing equipment, and change of site have become known as Scale-Up and Post approval Changes, or SUPAC. Under SUPAC, equipment within the same class and subclass are considered to have the same design and operating principle. For example, a change from a planetary mixer from manufacturer A to another planetary mixer from manufacturer B would not represent a change in design or operating principle and would be considered the same. Note that SU stands for scale-up during original dossier assessment, not SU development.
A change from equipment in one class to equipment in a different class would usually be considered a change in design and operating principle. For example, a change from a planetary mixer to a dispersator mixer demonstrates a change in operating principle from low-shear convection mixing to high-shear convection mixing. These types of equipment would be considered different under SUPAC.
Applicants should carefully consider and evaluate on a case-by-case basis changes in equipment that are in the same class but different subclasses. In many situations, these changes in equipment would be considered similar. For example, in Section III, mixing, under the convection mixers, low shear. A change from an impeller mixer (subclass) to a planetary mixer (subclass) represents a change within a class and between subclasses. Provided the manufacturing process with the new equipment is validated, this change would likely not need a Changes Being Effected (CBE) Supplement. At the time of such a change the applicant should have available the scientific data and rationale used to make this determination.
Packaging of pharmaceutical dosage forms and medical devices have many requirements in common with other commercial products. Package design must address the finished products’ needs, which include,
- Physical and chemical properties of the product
- Deteriorating factors in the environment
- Process requirements
- Package machine operation
- Storage and distribution requirements
- Distribution flow and timing
- Methods of distribution
In conclusion, special cares and attentions are required in the design and fabrication of machineries and equipment, used in pharmaceutical industries. These special case and attentions are also provided for few other industries viz. food and biotech.Due to these special considerations manufacturing or fabrication cost of these machineries and equipment go up. As a result, the equipment and machineries used in pharmaceutical industry are costlier than similar capacity/size machineries and equipment made for other industries.
(The author is a practicing chemical engineer based in Mumbai)