Single-Use Redundant Filtration - The authors describe a new assembly for bulk and final drug product filling operations. - BioPharm International

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Single-Use Redundant Filtration
The authors describe a new assembly for bulk and final drug product filling operations.


BioPharm International
pp. 38-41

COST ANALYSIS


Table I: Capital and validation cost. Capital and validation costs are taken over 10-year expected lifetime of the facility.
Traditionally, the comparison of single-use versus stainless-steel processes is made on the basis of consumable cost versus capital cost, but other costs must also be taken into account to make an accurate comparison, including labour, validation and quality. Selection of the cost minimum option depends on the specifics of the application and accurate accounting of the associated costs of each technology. Labour rates and process costing assumptions are taken from Biosolve cost modelling software (Biopharm Software Solutions). Tables I and II summarize the results of the cost analysis for a typical redundant filtration process using two 10 in. cartridges. The costs assumed here are representative of industry costs; it is assumed that difference in cost for utilities and materials (e.g., CIP solution, water for injection) does not significantly affect the cost comparison. The costs of pump and extractables–leachables validation are similar for both stainless steel and singleuse setup, so these costs were excluded from the analysis.


Table II: Cost per batch. The cost calculations in this table are based on 12.5 h batch time for stainless steel setup and 6.5 h batch time for single-use assembly. The batch time is lower for single-use assembly due to elimination of preparation steps, cleaning procedure and ease of handling.
SURF assemblies offer further benefits over stainless-steel setups. Equipment turnover for new products is quicker with single use assembly. For example, additional testing and cleaning time associated with equipment release and documentation is reduced or eliminated if singleuse technologies are used. It also provides more production flexibility because single-use assemblies can be made to order in the size and configuration required with the need for additional equipment or validation. It also eliminates the need to have multiple setups in place to meet the production demands of different products.

CONCLUSIONS

This study identified a suitable design for redundant filtration operations by utilizing single-use technology. An optimized utilization sequence for preparatory steps was designed and tested. Conducting a pre-use integrity test on a pre-sterilized redundant filtration setup can be challenging, but an effective filter wetting step is important to avoid false negative integrity test results. For highvalue products, the drying step after integrity testing is crucial to minimize product dilution. All preparatory steps and filtration operations can be successfully performed on a single-use assembly. SURF assemblies are robust and efficient disposable solutions for bulk and final fill processes.

Ranjeet Patil, is a process engineer II; Michael Felo, is an applications engineer consultant; and George Oulundsen, is a process engineer III, all at EMD Millipore.

REFERENCES

1. Parenteral Drug Association (PDA), Journal of Pharmaceutical Science and Technology, 62 (S-5) (2008).

2. FDA, Sterile Drug Products Produced By Aseptic Processing—Current Good Manufacturing Practices (Guidance for Industry, (Sept. 2004, Rockville, MD).

3. European Commission, Guidelines to Good Manufacturing Practice—Manufacture of Sterile Medicinal Products, Annex 1 (Nov. 25, 2008, Brussels, Belgium).

4. Lentine et al, Bioprocess Intl. 4 (6), 44–47 (2006).


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