Scale up-bioprocess

Question 1

What is scale-up studies?

Answer 1

Scale up studies refers to the act of using results obtained from laboratory studies for designing a prototype and a pilot plant process, construction a pilot plant and using pilot plant data for designing and constructing a full scale plant.

Question 2

Why conduct scale up studies?

Answer 2

• Allows investigation of a product and process on an intermediate scale before large amounts of money are committed to full scale production.
• Usually not possible to predict the effects of many-fold increase in scale.
• These studies are carried out at the laboratory or even pilot plant scale fermentors to yield data that could be used to extrapolate and build the large scale industrial fermentors with confidence that it will function properly with all its behaviours anticipated.

Question 3

What’s the importance of scale up studies

Answer 3

• To build industrial size fermentor capable or close of producing the fermentation products as efficient as those produced in small scale fermentors.
• During scale up, as size of fermentation increases, various parameters measured might not show a predictable linear co-relationships. Hence, certain parameters need to be modified and adjusted during scale up studies. The objectives of scale up studies is to get same fermentation efficiency as obtained in small scale fermentors at most economical values.

Question 4

Pilot plant crucial studies

Answer 4

• Determining the various operational parameters for optimized oxygen supply to the fermentation process
• Selection of optimum operative modes of the fermentor
• Determining the changes in rheological properties and its effect on the fermentation process.
• Modeling and formulation of process controls
• Sensors and controls

Question 4

Pilot plant crucial studies

Answer 4

• Determining the various operational parameters for

Question 5

Steps in Scale-up

Answer 5

• Define product economics based on projected market size and competitive selling and provide guidance for allowable manufacturing costs.
• Conduct laboratory studies and scale-up planning at the same time.
• Define key rate-controlling steps in the proposed process.
• Conduct preliminary larger than laboratory studies with equipment be used in rate-controlling step to aid in plant design.
• Design and construct a pilot plant including provisions for process and environmental controls, cleaning and sanitizing systems, packing and waste handling systems and meeting regulatory agency requirements.
• Evaluate pilot plant results (product and process) including process economics to make any corrections and a decision on whether or not to proceed with a full scale plant development.

Question 6

What does initial scale up studies mean

Answer 6

• Preliminary work are carried out at the level of petri dishes and small scale laboratory fermentors to establish whether the process and production of product is technically viable on a small scale.
• Additional parameters not provided by petri dishes studies and for more confidence are obtained by carrying further studies using submerged liquid fermentation using various sizes laboratory scale fermentors and even a pilot plant fermentor.

Question 7

What are the rules for scale-up

Answer 7

1. Similarity in the geometry and configuration of fermentors used in scaling up.
2. A minimum of 3 or 4 stages of increment in the scaling up of the volume of fermentation studies.
   - Each jump in scale should be by magnitude/power increase and not an increase of few litres capacity.
   - Slight increase in the working volume would not yield significant data for scale up operation.

Question 8

What are the studies carried out during scale-up

Answer 8

1) Inoculum development
2) Sterilization establishing the correct sterilization cycle at larger loads
3) Environmental parameters such as nutrient availability, pH, temperature, dissolved oxygen, dissolved carbon dioxide.
4) Shear conditions, foam production

Question 9

What a pilot plant can be used for?

Answer 9

• Evaluating the results of laboratory studies and making product and process corrections and improvements.
  -Producing small quantities of product for sensory, chemical, microbiological evaluations, limited market testing or furnishing samples to potential customers, shelf life and storage stability studies.
• Determining possible salable by-products or waste stream requiring treatment before discharge
  -Providing data that can be used in making a decision on whether or not to proceed to a full-scale production process, and in the case of positive decision, designing and constructing a full-size plant or modifying an existing plant.