Filtration

Uniting Bulk Final Filtration and Bulk Dispensing to Tackle Inefficiency

Uniting Bulk Final Filtration and Bulk Dispensing to Tackle Inefficiency_People working in a biopharm cleanroom_Parker Bioscience FiltraitonBiopharmaceutical manufacturers have traditionally implemented bulk final filtration and bulk dispensing as two separate unit operations – with multiple operators assigned to carrying them out. However, this approach can be inefficient in a number of ways.

Drug product needs to be transported between the two unit operations. This movement of product and materials not only wastes operators’ resources but also increases the time taken to complete the final stage of the manufacturing process. There is also a risk of product loss and contamination during the transition between two unit operations.

 

Implications for biopharmaceutical manufacturers

The manual nature of bulk final filtration and bulk dispensing as two separate unit operations also has implications for biopharmaceutical manufacturers. Involving multiple operators in the process increases the potential for variability and human error. This can lead to product losses and in the event of contamination, the loss of entire batches – with the resulting financial losses, reputational damage and market shortages of life-changing drugs.

Human error can also lead to inaccuracies; for example, more product being transferred to a bottle or bag than is required can have a significant impact on production and can be financially damaging too – especially given the high value of the product when it reaches this stage.

There are also cost implications of the man-hours dedicated to the two unit operations – as well as the fact that specialist staff may be more effectively employed elsewhere in a process, rather than being used to manually operate pumps and valves.

Using a separate open process for bulk filling after filtration can expose a sterilized batch to potential contamination and given the product is in its most concentrated and valuable format at this time, the consequences can be grave.

 

How can efficiency be improved?

Uniting Bulk Final Filtration and Bulk Dispensing to Tackle Inefficiency_SciLog FD System_Parker Bioscience FiltrationParker’s SciLog® FD (Filter and Dispense) System automates, standardizes and encloses final bulk filtration and dispense operations. The system brings bulk final filtration and bulk dispense into one unit operation, which is optimized for both functions.

The SciLog® FD System removes the variability and potential for human error that is inherent in manual processes and it allows manufacturers to apply pre-defined recipes for dispensing. Stages such as sampling and product recovery are automated, while in-line pre and post-use filter integrity testing is built into the system.

 

How does the SciLog® FD improve efficiency in bulk final filtration and bulk dispense?

  • The number of operators is reduced, which means that fewer man-hours are tied-up in carrying out time-consuming manual tasks – and specialist staff can be freed up to work on other operations.  
  • By automating the process, the risk of human error is reduced. Filling accuracy can be increased – thus maximizing yield – and there is less risk of a costly contamination incident and batch loss.
  • Combining bulk final filtration and bulk dispense into one unit operation cuts the waiting time previously incurred by running two unit operations. The whole process can therefore run more quickly – and man-hours aren’t wasted.
  • The use of the SciLog® FD simplifies the supply chain, with the hardware and consumables - including manifolds used in biopharmaceutical processing - designed in tandem and available from a single source.

 

Additional advantages

Reliability

  • As the SciLog® FD standardizes and automates final bulk filtration and dispense operations, it eliminates process variability and enables batch repeatability. Standardized, reliable programming ensures reliability and robustness in the process. 


Enclosure

  • Enclosing the process means that the product is protected and the risk of any contamination is greatly reduced. In addition, the operator will not be exposed to active biopharmaceutical compounds.
  • By enclosing the process, dispensing can also be performed in areas of lower classification, eliminating the requirement for vertical laminar flow cabinets.


Data and reporting

  • The SciLog® FD automates data acquisition and analysis and generates reports: the risk of transcription errors, caused by an operator making mistakes in reading a balance and recording information, is therefore eliminated.
  • It also has an integrated label printer which allows container and documentation labelling with recipe parameters.


Operator training

  • As the process is standardized, training is made simpler and easier – which saves manufacturers’ man hours, and again, allows specialist staff to be utilized more effectively.


Compliance

  • The SciLog® FD is offered as a fully validated package. It also has fully programmable alarms and interlocks to protect the product and the process and its calibrated SciPres pressure monitors ensure validated limits are not exceeded.
  • The system generates a full audit trail - and batch record data is securely retained.

 

Gain a greater understanding of the SciLog® Filter and Dispense FD at the SciLog® suite at Parker Bioscience Filtration’s site at Birtley, UK.

You can undertake interactive demonstrations with the SciLog® FD system and run trials to determine how the equipment can be used to optimize your processes. This can also be carried out virtually through a video link.

Contact us to book into the SciLog® suite.

Learn more about the SciLog® FD system.

 

Uniting Bulk Final Filtration and Bulk Dispensing to Tackle Inefficiency_David Heaney_Parker Bioscience Filtration

This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK

 

Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively ensuring the quality of the final product. 

 

Related content

Defining Our Unique Contribution to the World

Improve Accuracy and Efficiency by Tackling the Eight Wastes of Lean

Optimizing Filtration of Bulk Biopharmaceutical Drugs

The Cost of Failing to Protect Your Final Biopharmaceutical Product

Reducing Human Error in Bioprocessing

Standardization and Control - Protecting Your People, Product and Reputation

Automating and Enclosing Bulk Fill Operations - the Way Forward?

Preventing Product Losses During Biopharmaceutical Manufacturing

Listening, Learning and Applying Knowledge in Product Development

 

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