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Application and Development of Auto Loading Systems in Freeze Dryers

Application of Auto Loading Systems


Nearly 60% biopharmaceuticals including antibodies, vaccines, peptides, proteases, hormones, cell growth factors and other drugs are lyophilized. Driven by great market demand, lyophilized products have high requirements in sterility and continuous manufacturing in accordance with the regulations on drug production and management.

According to GMP guideline, the products are transferred to lyophilizers shall be protected from contamination. Auto Loading Systems play an increasingly important role in facilitating lyophilization of parenteral, cytotoxic, and other freeze-dried products with special handling requirements. Auto Loading Systems minimize the risk of contamination through human intervention in the loading and unloading of freeze dryers, it can also increase the production efficiency and reduce human error, thus ensuring the high quality and efficient production of drugs.

Development of Auto Loading Systems

  • Manual Loading & Unloading

In the early stage of lyophilized formulations manufacturing, manual loading and unloading production mode has generated high risks of contamination. In the whole loading and unloading process, lyophilizer’s loading and unloading ports are completely exposed. Processes from the out-feed of filling machine to the in-feed of lyophilizer and from lyophilizer to the capping machine was not closed, which made the products easy to contaminate; without Barrier Systems, operators who were in direct contact with products became the biggest source of contamination.


  • Semi-auto Loading Systems

To reduce human intervention, Semi-auto Loading Systems were used to upgrade workshops, such as retrofitted into an existing lyophilization suite, to meet the requirements of regulations such as cGMP. Semi-auto Loading Systems considered the risk of aseptic transport and the integration of RABS to reduce the risk of operators’ aseptic operation as much as possible. A semi-automatic trolley can satisfy the loading and unloading process of one or more lyophilizers.

However, as the lyophilizing frame was generally used to assist the transfer of vials, it reduced the lyophilizer’s loading capacity by more than 5% while increasing the risk of cross-contamination during the manual transferring and placement of the frame.


  • Ÿ Auto Loading Systems

At present, Tofflon Auto Loading Systems are categorized into Fixed Loading Systems (Row-by-Row), Flexible Loading Systems (AGV) and Mixed Loading Systems (Mixed), providing the best choice for customers based on their requirements and workshop layout. Wide range of solutions for Loading Systems, Freeze Dryers (single floor or two-floor, single side loading & unloading or pass through systems, external condenser or internal condenser, etc) and Barrier Systems (oRABS, cRABS, Aseptic Isolator or Toxic Isolator).


Ÿ

  • The automatic loading and unloading system can transfer vials through the slot door of lyophilizer.

  • Can be used to the in-feed and out-feed of single or multiple lyophilizers.

  • It’s suitable for a variety of loading processes and vial types, with higher efficiency and quality.

  • Based on GAMP5 compliance control system, it has fully considered the risk assessment and risk management of the system while satisfying the electronic record and electronic signature of 21CFR Part 11.

  • Controlled by servo motor and DC motor, it has no hydraulic component and fully meets the GMP sterility requirements.


Summary


“Automation, Isolation, Continuouus Processing and Systems Integration” are becoming trends for aseptic processing of lyophilized injectables. With the implementation of cGMP, Auto Loading Systems will play an important role in the production of lyophilized parenteral. Equipped with more advanced isolation systems, it can reduce manual intervention in the critical area, thus avoiding the cross contamination caused by human errors while protecting safety of operators as well as products.


Today the pharma and biotech industry in USA, Europe and Japan are mainly requesting the use of auto loading systems for aseptic applications. And the industry in emerging markets is increasingly requesting auto loading systems for freeze dryers to meet increasing cGMP expectations.

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