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全球醫藥包裝機械正朝GMP方向發展

文字:[大][中][小] 手機頁面二維碼 2016/4/29     瀏覽次數:    

  我國醫療器械醫藥包裝機械的高端水平與國外差距并不很大,部分設備已與當前的世界最新技術進展實現了同步,但總體水平還是與國外先進水平存在著不小的差距。

  當前,我國的醫藥包裝機械已填補了基本品類和基本技術的空白,但在產品研發的資金來源、試驗條件、產品的穩定性、自動控制等方面與國際領先水平還存在差距。在自控技術方面,國外的醫藥包裝機械設備已經基本實現了智能化、人性化的設計,而我國醫藥包裝機械在PLC控制、界面控制相對落后。而除了運用PLC控制技術外,必須同時在材料、設計以及所有相關的各個環節上作出配套選擇,才可能實現智能化的控制。同時,我國醫藥包裝機械在穩定性還比較欠缺,這可能會導致產品質量方面的問題,并影響到整條包裝線。

  醫藥包裝機械出眾的穩定性,對于產能大、產品種類多的醫藥生產企業而言,是非常關鍵的要求,因為不穩定的設備容易導致停產斷線并影響產量。影響醫藥包裝機械穩定性的因素主要有材料、元器件和基礎傳動裝置。首先,材料與元器件的低級配置會嚴重影響設備的穩定性,但是當前我國有些企業出于成本考慮而采購低級甚至劣質的材料和元器件。第二,包裝機上的基礎傳動裝置也是影響包裝機械穩定性的因素之一。當前,我國的醫藥包裝設備基本以鏈條、拖輪、擺稈等基礎傳動裝置為主,這便會給機械的穩定性帶來隱患,而國外的醫藥包裝機械基本上都采用了伺服驅動系統。應該說,企業選擇一個伺服電機并不是一件很困難的事情,但是企業通常會考慮到引入伺服電機的潛在成本壓力。企業從傳統的傳動方式轉而應用伺服電機,進而需要給其它機構或者設備上也配套伺服電機,這樣,伴隨著控制精度的提高,成本也隨之增加,令很多醫藥生產企業沒有能力承受。

  以分裝機為例,國內最早的分裝機的生產能力為每分鐘40瓶,隨后為每分鐘60瓶,直至發展到每分鐘120瓶。國外的同類設備在我們實現60瓶/分鐘的生產速度時,就達到了300瓶/分鐘。我國進行分裝機自主研發的哈飛集團的產品,每分鐘的產量和設備的功能等與國外設備沒有差異,但穩定性不夠出眾。如果國外同類分裝機設備可以就300瓶/分鐘的生產速度實現穩定生產的話,那么國內的同類設備是生產速度一般只能夠穩定于280瓶/分鐘。

  再以鋁塑包裝機為例,我國國產的鋁塑包裝機與國外相比差距較大,體現每個具體的工作環節。比如,我國生產的鋁塑包裝機的網紋紋路深,且不均勻。又譬如,上料工序在國內外的各類型包裝機上都是一個非常關鍵且較為薄弱的環節,但是與國外相比,我國醫藥包裝機的上料工藝顯得更為薄弱。我國還有滾刷式鋁塑包裝機這種采用特殊上料工藝的專用機械。就上料工序的生產能力來看,以膠囊為例,國內設備的每分鐘的產量為600粒,片劑為每分鐘700粒~800粒,而國外鋁塑包裝機的上料工序可以實現2000粒/分鐘的生產速度。

  所用材料、加工手段以及機構的配套協調等因素,直接影響了鋁塑包裝機的生產速度及運行狀況。

  當前全球醫藥包裝機械正朝著更加符合GMP認證的方向發展。對于醫藥包裝機械而言,深度發展的方向就是速度更快、更加穩定、自動化控制水平更高、操作更加人性化、更加方便、更加便于清洗等等。如何沿著GMP認證的深度方向去發展以及這中間的發展策略,需要中國醫藥包裝機械行業進行深入的思考。

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