Aseptic formulation processing is the manipulation of a sterile active pharmaceutical ingredient (API) or pharmaceutical product in a carefully controlled environment using aseptic technique to produce a sterile end product. Aseptic formulation processing is a risk management program that ensures the safety and integrity of the pharmaceutical product by confirming the transfer of high potency formulation ingredients without any risk of contamination into pre-sterilized vials or containers. Maintaining a controlled environment is essential in processing the aseptic formulation as the quality of the final product and the sterility of the manufacturing procedure are maintained due to the sterile environment. The environmental conditions required for aseptic processing are maintained by sterile air supply via laminar airflow machines in aseptic formulation processing facilities. During the final product packaging process, technical measures should be taken such as handling sterile materials in a controlled environment to control microbial and particulate contamination to acceptable levels. This process is done manually or using automated aseptic filling devices. However, to improve aseptic processing procedures of formulations in the pharmaceutical industry, the Parenteral Drug Association (PDA) published its Aseptic Validation Technical Report in 1981. After that, several regulatory authorities issued guidelines for the aseptic processing of pharmaceutical products.
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Aseptic Formulation Processing Market: Drivers and Constraints
Aseptic processing of the formulation is a difficult process because transferring the material from one process to another, without operating errors and without manual contamination, poses a high risk to the finished pharmaceutical product. This fueled the demand for aseptic filling devices, which further boosted the growth of the aseptic formulation processing market. Additionally, regulatory agencies around the world are developing and enforcing stringent environmental and process control requirements for the aseptic handling of formulations. These factors are driving interest in advanced aseptic technologies, further increasing the demand for superior contamination control devices. Rising awareness of the use of highly integrated sterile devices and the development of new therapeutic drugs are expected to drive the aseptic formulation processing market. Rising pharmaceutical supplies and improved sanitary packaging method are some of the major driving factors for the aseptic formulation processing market. However, the high cost of service cost due to high maintenance clean rooms, aseptic areas and formulation filling equipment is likely to hinder the growth of the aseptic formulation processing market.
Aseptic Formulation Processing Market: Overview
The global aseptic formulation processing market is expected to grow exponentially owing to technological advancements and growing product penetration in the market. Among the technology segments, automated technology type is expected to grow with the highest CAGR in the aseptic formulations processing market over the forecast period owing to the added benefits such as reduced packaging time, less manual errors. Pharmaceutical companies in the end-user segment are expected to generate maximum revenue owing to the increasing adoption of aseptic formulation processing in pharmaceutical companies over the forecast years. Due to the improvement of GMP (good manufacturing practices) and strict regulations, the adoption rate of these aseptic formulation processing devices by end users, it is estimated that aseptic formulation processing is the market at the fastest growing from 2018 to 2028.
Aseptic Formulation Processing Market: Regional Outlook
North America is expected to be the global market leader in aseptic formulation processing due to better availability of resources and presence of established pharmaceutical companies. The Asia Pacific aseptic formulations processing market is expected to be the fastest growing market for global aseptic formulations processing, owing to its growing outsourcing from the pharmaceutical industry and CRO contract research organizations in the region. Europe is expected to take the second largest market share in the global aseptic formulation processing market throughout the forecast period. The aseptic formulation processing market in the Middle East and Africa is expected to grow slowly due to the lack of technological reach.
Aseptic Formulation Processing Market: Key Players
Some of the key players identified in the global aseptic formulations processing market are Robert Bosch Packaging Technology GmbH, EI Du Pont De Nemours and Co, JBT Corporation, Kwang Dah Enterprises Co. Ltd., SHIBUYA CORPORATION, ITECO srl, Greatview Aseptic Packaging Co . , Ltd, Powder Systems Limited and GEA Group, among others.
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