PHARMACEUTICAL TECHNOLOGY

PHARMACEUTICAL TECHNOLOGY

The development and implementation of machinery is responsible for one of the great advances in human history, the industrial revolution. Machinery encompasses a vast range of products, ranging from huge industrial turbines costing millions of dollars to the common lawn mower, but all machinery has one common defining feature: it either reduces or eliminates the amount of human work required to accomplish a task. Machinery is critical to the production of much of the Nation’s goods and services because nearly every workplace in every industry uses some form of machinery. From the oil derrick that pumps out oil to the commercial refrigerator in use by your favourite restaurant, machinery is necessary for the way we live today. Thus while people never use or even see most of the machinery that makes their lifestyles possible, they use the products it makes every day.

Most machinery is made of metal, which gives the end product strength and durability, but which necessitates specialized procedures in production. Each part needs to be designed to exacting specifications to ensure proper function of the finished product. Techniques such as forging, stamping, bending, forming, and machining are used to create each piece of metal, thousands of which then need to be welded or assembled together in the largest machines. At each stage of production and assembly, extensive testing takes place to maintain quality control standards. Due to the great variety of machinery produced by industry, firms specialize in designing and producing certain types of equipment for specific applications.

In Early 60's and 70's the pharmaceutical industry big or small were forced to imported machines from Europe for their processing and packaging needs. During the phase entrepreneurs, engineers in India realized the need for development in the sector for better improvement and meeting requirements of the fastest growing Industry Pharmaceutical process and packing. In mid 70's Indian government introduced very high import duties and restrictive import licensing policies. This resulted in a spark in the Indian engineers to prove their excellence as enterprises to manufacture machines locally. Engineers had the skills and now the support of industry and associations were form to cater the domestic market for better improvement as perhaps the only route for the pharmaceutical industry to enhance production and cater to the growing demands of the domestic market.

Foreign manufactures had a stronghold on the market but today the Engineering excellence of Indian manufactures had turn table not only to the domestic market but all have proved to the world our capabilities. Indian Pharmaceutical industry stands fifth largest producer of drugs and pharmaceutical after USA, Japan, Europe and China.

With this big a size of the industry a proper setup development plan and skill to cater the need was inevitable. Pharmaceutical Industry grew at the most fastest rate in India for its mineral rich resources, ore availability, raw material power house of such basic ingredients which were cheaply available in local market strengthen the growth. To support the industry Pharmaceutical Machinery Manufactures also upgraded themselves and adapted to a marketing plan. To ensure proper flow and meeting technological upgrades manufactures had to plan a proper strategy for not only meeting requirements but also giving technological upgrade the equipments for faster and efficient working.

Manufacturing of pharmaceutical products and of chemical and botanical products for medicinal purposes, production sector that includes:

- Test, enhancement and production of active medicinal substances which, due to their therapeutic properties, are used in the manufacture of pharmaceutical products.
- Production of blood derivates for pharmaceutical uses;
- Production of chemically pure sugars;
- Gland processing and production of glandular extracts.

Belonging to the same sector, includes:

- Production of drugs recorded as such in a national register displaying specific component formulation and quantities and possessing a concrete pharmaceutical form which allows them to be assembled; immune serum and other blood components; vaccines, varied packaged/unpackaged medicinal products for retail sale, including homeopathic preparations, dental cavity fillers and cements for bone reconstruction and chemical birth control preparations;
- Production of drug impregnated or coated cotton wool, gauze, dressings, adhesive plasters, etc. production of sterile surgical sutures.

The companies affected by this research display a production cycle which includes the preparation of packaged/unpackaged medicines for retail sale; chemical birth control preparations; test, enhancement and production of active medicinal substances which, due to their therapeutic properties, are used in the manufacture of pharmaceutical products; production of chemically pure sugars.



PHARMACEUTICAL INDUSTRY MANUFACTURING PROCESSES: GENERAL CONSIDERATIONS

Within the pharmaceutical industry, all basic procedures for drug production are performed according to so called GMP (good manufacturing procedures) (official national pharmacopoeia- edition VII). The above procedures are an integral part of the broader Quality Assurance verification system, which brings together all specifications, procedures and structures aimed at assuring that products meet required quality standards. All production facility organizational functions contribute to the verification system’s implementation. The national official pharmacopoeia includes a chapter listing certain useful definitions for the interpretation of the GMP (good manufacturing procedures). Listed hereunder are the definitions relating to the terms “Medicament, Manufacture, Batch, Validation, and Quality Control”.

Medicament:
Any substance or chemical composition displaying curative, prophylactic, diagnostic properties or which allows restoration, modification or correction of organic functions in humans and animals.

Manufacture:
All operations relating to the production of medicaments especially, those relating to the handling of raw materials, mixture preparation, realization of pharmaceutical forms as well as the filling, packaging and labelling of containers.

Batch:
The bulk of a specific medicament manufactured during a single production cycle. The essential feature of a batch is its homogeneity.

Validation:
The documented implementation of a specific verification program aimed at systematically obtaining a product meeting predetermined specifications. The validation process affects manufacturing processes, quality control, plant efficiency and environmental considerations.

Quality Control:
The activities and interventions aimed at ensuring the production of uniform medicament batches to meet predetermined specifications.

The application of quality control rules is targeted to obtaining a product for human or animal administration for curative and/or diagnostic purposes.

Consequently the drug must display low contamination and/or sterility characteristics not required of other products. As a result, employee working conditions are quite unique and aimed at preserving the finished product. A drug production work environment includes areas maintained at various levels of decontamination thanks to ambient air filtering systems, operator protection devices and measures, particularly stringent hygiene standards.
These measures, while ensuring that the drug is free from contaminants, also avoid direct worker contact with pharmacologically active and thus hazardous substances. Daily exposure threshold values (TLV) have been set to ensure worker protection. Threshold values have been arbitrarily set at 1:100 of the lowest pharmacologically active dose (minimum effective dose) bearing in mind that the minimum effective dose was calculated on the basis of conventional drug administration and not resulting from worker exposure.

WORK CYCLE: GENERAL DESCRIPTION

Companies operating in this sector perform the following principal work cycles.

1) Production procedures common to all types of pharmaceutical forms:
a) Weighing of active principles and excipients;
b) cleaning-sterilization of plant systems and work areas.
2) Production of solid pharmaceutical forms.
3) Production of semi-solid pharmaceutical forms.
4) Production of liquid pharmaceutical forms.
5) Packaging lines for the various pharmaceutical forms.


General Drug Production Work Cycle:




Detailed study on process requirements, and corral for equipment requirement, the machinery manufacturing industry is comprised of seven more detailed industrial segments, Three of these make machinery designed for a particular industry—called special purpose machinery: agriculture, construction, and mining machinery manufacturing; industrial machinery manufacturing; and commercial and service machinery manufacturing. The other four segments make machinery used by many different industries—called general purpose machinery: ventilation, heating, air-conditioning, and commercial refrigeration equipment manufacturing; metalworking machinery manufacturing; engine, turbine, and power transmission equipment manufacturing; and other general purpose machinery manufacturing.

Industry segment:

1. Agriculture, construction, and mining machinery manufacturing
2. Metalworking machinery manufacturing
3. Ventilation, heating, air-conditioning, and commercial refrigeration equipment manufacturing
4. Industrial machinery manufacturing
5. Commercial and service industry manufacturing
6. Engine, turbine, and power transmission equipment manufacturing
7. Other general purpose machinery manufacturing


All these segments contribute to the pharmaceutical industry, from construction, metal working, heating, air-conditioning, Industrial machinery, service industry manufacturing, power transmission equipment manufacturing, and general purpose machinery.

The size of an establishment also contributes to how some machinery is produced. Large firms involved in manufacturing machinery tend to have a multistage production process, with separate teams of individuals responsible for design and testing, manufacture of parts, and for assembly of the finished product. Nonetheless, there is considerable interaction between the various types of workers; for example, design offices are often located near the factory floor to promote interaction with production workers. Small establishments, in contrast, may have a handful of workers responsible for the entire production process.

The machinery manufacturing industry continues to evolve. Domestic and foreign competition has required the industry to adopt new technologies and techniques to lower costs and raise the productivity of its workforce. For example, using high-technology production techniques, including robots, computers, and programmable equipment results in productivity gains and helps to maximize the use of available equipment and workers. Increasing technology and automation also reduces the number of unskilled workers needed in the production process.

Pressures to reduce costs and maximize profits have also caused manufacturers in the industry to adopt new business practices. One example is the practice of contracting out support functions, such as janitorial and security jobs, and increasingly some administrative services and warehouse and shipping jobs. Rather than employ workers directly for these jobs, a manufacturer will often contract with another company that specializes in providing these services. This practice reduces costs by forcing service providers to compete for the work, allows manufacturers to focus on their core design and production activities, and increases manufacturers’ flexibility by letting them add and subtract contract workers more easily than they could hire and fire employees.
These changes have had a profound effect on the machinery manufacturing workforce. By automating many of the production processes and outsourcing many of the administrative and support functions, it has reduced the need for many less skilled workers and increased the skill level required for the remaining workers. These changes are allowing the industry to remain competitive and meet the demand for machinery that industries rely on.

Pharmaceutical machinery manufactures have understood the concept behind the process involvement for development of drug, machinery are developed as per client process requirement. Need for such development required in-depth study and monitoring process requirements of clients. Machinery manufactures updated their facilities by latest automated machinery for manufacturing parts, in addition to this there are also other visible trends that can explain committed interest of Indian machinery manufacturers further:

- Manufactures are going for CNC machine to get quality output

- Use of efficient and modern gadgets in the machine, like, VFD, PLC etc.

- Quality approvals and Trademarks, getting ISO approval and international certificate approval for quality manufacturing are also a part of dedication.

- To adapt and implement prototype machines are imported by manufactures.

- Tie-up & Collaboration for technology transfer with international manufactures.

- Expanding high tech facility to meet rising global demand.

Current good manufacturing practice (CGMP) requirements are set forth in quality system regulation. The requirements is part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance.


Article By:
Piyush Tripathi
Cell: +91-9824663306