Berkshire Sterile Manufacturing<\/a> implemented a cost-effective strategy using a flexible isolator based sterile manufacturing system engineered by Fedegari.[\/vc_column_text][vc_empty_space height=”60px”][\/vc_column_inner][vc_column_inner width=”1\/6″][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner offset=”vc_hidden-lg vc_hidden-md vc_hidden-sm”][vc_single_image image=”2138″ img_size=”full”][\/vc_column_inner][\/vc_row_inner][vc_empty_space height=”20px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” css=”.vc_custom_1551448777969{margin-top: 60px !important;margin-bottom: 60px !important;}” el_id=”content”][vc_column width=”1\/2″][vc_column_text css_animation=”fadeIn”]Berkshire Sterile Manufacturing and Fedegari bring flexible isolator-based sterile manufacturing to market.<\/p>\nMany Aseptic Contract Manufacturing Organizations (CMOs) face the challenges of small batch sizes, varying primary container types and sizes, and customer expectations of the latest technologies in sterile manufacturing.<\/p>\n
It is cost prohibitive to have multiple production lines, each of which is dedicated to one primary container type (vial, syringe, cartridge, or custom).\u00a0 Isolators represent the current trend in sterile filling technologies, but can add significant capital expense to process manufacturing.\u00a0 Isolator based \u201cflex\u201d lines capable of multiple containers have been used by some industries, but most are unable to accommodate bulk glass vials and some require previous treatment with vapor hydrogen peroxide for all primary container packaging\u201d, explains the CEO of BSM, Shawn Kinney.<\/p>\n
Berkshire Sterile Manufacturing is implementing a cost-effective strategy using a flexible isolator based sterile manufacturing system to face all this challenges and Fedegari is proudly involved in this endeavor with experts in various aspects of fill, finish and contamination control technologies.<\/p>\n
The result of this collaboration is an isolator based filling system that is able to fill the following primary containers: bulk glass vials, pre-sterilized nested vials (glass and plastic) and syringes (glass and plastic), pre-sterilized nested cartridges (glass and plastic), and custom containers (glass and plastic).<\/p>\n
The system works with both liquid and lyophilized products and the primary containers do not have to be exposed to hydrogen peroxide before entering the isolator.[\/vc_column_text][vc_empty_space][vc_video link=”https:\/\/www.youtube.com\/watch?v=zRObu9Jd_p4″ align=”center”][vc_empty_space][\/vc_column][vc_column width=”1\/2″][vc_row_inner][vc_column_inner][vc_empty_space height=”60px”][\/vc_column_inner][\/vc_row_inner][vc_column_text]\u201cMore than supplying state-of-the-art equipment to Berkshire new facility, we are investing in this partnership to face the challenges of the post-blockbuster pharma industries. We are pleased that BSM has recognized Fedegari as a partner who shares their vision for an advanced, cost-effective and flexible pharma manufacturing. We have worked together with BSM to design and develop the highest performance customized solutions for the American market<\/em>\u201d, said Giuseppe Fedegari, president of Fedegari Group.<\/p>\nThe biopharmaceutical firm focus on contract manufacturing sterile drugs in the pre-clinical and clinical phases for pharmaceutical, biotech, and medical device companies at its new facility. Berkshire Sterile\u2019s services include the filling of syringes, vials, cartridges, and dual chamber devices and also provide formulation development, terminal sterilization, freeze-drying, analytical chemistry and microbiological testing, quality assurance, and stability studies.<\/p>\n
BSM\u2019s goal is to address the risks that are associated with drugs manufactured by small sterile drug manufacturing companies that lack adequate modern facilities and rigorous quality systems. The company wants to alleviate these concerns by using state-of-the art manufacturing equipment, isolators, flexible sterile filling equipment, and modern cleanroom and terminal steam sterilization capabilities.<\/p>\n
The new Berkshire Corporate Center, inaugurated last October, is equipped with the newest and most advanced technologies in the market \u2013 including Fedegari process equipment \u2013 to manufacture sterile drugs.<\/p>\n
FDA, EMA and other regulatory bodies have stated for years that contamination in cleanrooms are mostly generated by human intervention and for this reason, the use of isolators for all products requiring aseptic fillings have been highly suggested. However, the lack of flexibility, cost and overall difficulty with employing this technology has hindered a wide embracement.<\/p>\n
Over the past 10 years, a revolution in terms of technology has occurred on filling and container systems, and partnerships with the most innovative companies in pharma manufacturing are allowing CMO\u2019s like Berkshire Sterile manufacturing to bring this technology to their customers.<\/p>\n
\u201cThis collaboration between BSM and Fedegari is a very promising beginning to a long and fruitful cooperation. Our partnership is making available the excellence in sterile manufacturing to improve drug industry productivity in many aspects\u201d, concludes Giuseppe Fedegari.<\/p>\n
Learn more at: http:\/\/berkshiresterilemanufacturing.com<\/a>[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=”60px”][vc_cta h2=”Discover our isolators and sterilizers” h4=”Flexible solutions to achieve the highest performances in sterile manufacturing.” txt_align=”center” style=”flat” color=”grey” add_button=”bottom” btn_title=”Learn more” btn_color=”black” btn_align=”center” btn_css_animation=”fadeIn” btn_link=”url:https%3A%2F%2Ffedegari.com%2Fen%2Findustrial-solutions%2F||target:%20_blank|”][\/vc_cta][vc_empty_space height=”60px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” css=”.vc_custom_1551450117939{background-color: #eaedf2 !important;}”][vc_column][vc_row_inner css=”.vc_custom_1552902064695{background-color: #c4161c !important;}”][vc_column_inner][vc_empty_space height=”20px”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"Berkshire Sterile Manufacturing is implementing a …<\/p>\n","protected":false},"author":17,"featured_media":2141,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[153],"tags":[389,154],"class_list":["post-2132","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en","tag-389","tag-news-en"],"yoast_head":"\n
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