Fluid Dynamics is the exclusive Australian and New Zealand representative of, and works closely with, SACOME, one of Europe’s leading manufacturers of tubular/tub-in-tube heat exchangers.
SACOME’s experts in thermal design for the process industry since 1975, and backed by HTRI, the worlds’ leading thermal design institute, have provided literally thousands of customized and reliable engineering solutions adapted to the customers’ needs.
One of the world’s largest pharmaceutical companies which produces a wide range of products in therapeutic areas including cardiovascular, thrombotic or metabolic disorders.
To calculate, design and manufacture all the tubular heat exchangers for their Insulin Plant in Frankfurt Germany.
To supply for the customer’s bioengineering production facility, with an approximate production capacity of 1.700 kg of insulin glargine per year, pharmaceutical grade heat exchangers to heat and cool different products such as protein suspensions, 30%-n-Propanol, or 10%-n-Propanol.
Product specifications and process:
Tubular heat exchangers were required to process different products including:
- Product solutions.
- Protein suspensions.
- 30% N-propanol.
- Regeneration solutions.
- Inputs chromatographies.
- 10% N-propanol.
- Bio-waste water
SACOME’s engineers worked in close collaboration with the client, taking into consideration its product portfolio and setting different thermal properties (density, specific heat, thermal conductivity and viscosity) for each case.
The main objective was to calculate an accurate thermal design of each of the different sections operating as point-of-use coolers/heaters as well as within batch processes and to select appropriate tube geometries and configurations with suitable Reynolds number and process velocities of the products to avoid liquid stagnation.
Design of tubular heat exchangers
The most significant point to be considered in selecting the correct equipment to be installed in a pharmaceutical application is achieving the highest levels of security, efficiency, and asepsis in all processes.
FDA and GMP Requirements
In this case, the heat exchangers had to comply with all FDA and GMP recommendations relating to velocities, self-drainability, inner roughness, absence of dead points, etc. which excluded the use of some types of exchangers, such as plate heat exchangers, that are incapable of complying.
With this in mind, SACOME recommended to the client its P-TFM-I tubular heat exchanger which has been specially conceived for pharmaceutical applications and has some significant features relevant to the proposed application:
Crevice Free Design
To avoid the growth and accumulation of colonies of bacteria and microorganisms, the SACOME range of heat exchangers for the pharmaceutical industry has been specially designed to avoid dead zones and include sterile flanges.
As required, the product channel, which includes the inner tubes, tubesheets, eccentrical reduction cones and bends, was fully electropolished to enhance the enhance passivation, make the surface easier to clean and sterilise and to get better corrosion protection.
SACOME’s engineers decided to use inner tubes in DIN 1.4435 (316L) with certified inner roughness Ra ≤ 0.8 µm (bright finish version) in accordance with ASME BPE standard.
Double Tube Design
Each heat exchanger was manufactured using double tube sheets to avoid cross contamination by service fluid leaking into the product side.
SACOME’s technical department analyzed the production, cleaning and sterilization programs of the different items, and fitted expansion joints to the heat exchangers to ensure their protection from thermal expansion.
The design conditions of pressures up to 40 bar, and the necessity to comply with GMP and FDA regulations meant that metallic ring DIN 1.4541 gaskets with two graphite layers enveloped in PTFE (Teflon) were fitted.
Inspections & Certifications
One of the key requirements for this project was the need for stringent programmed inspections with demanding documentary and certification requirements.
The Quality Plan carried out for this project included the following inspections before, during and after manufacture:
- Visual inspection.
- Dimensional control.
- Hydraulic and pneumatic test.
- Welding procedures acc./ EN287-288, with TÜV approved norms.
- Non-destructive tests (dye penetrants) 100%.
- X-ray longitudinal butt welds.
- Chemical composition analysis.
- Intergranular corrosion test acc./ DIN50914.
- Delta ferrite in straight seam welds.
- Roughness analysis.
The client’s project engineering consultants inspected the different levels of manufacture from the delivery and acceptance of raw materials to manufacturing, validation of each test, electropolishing and certification of finishing.
Production of the insulin glargine:
Units of thermal power:
Scope of supply of tubular heat exchangers:
Number of sections:
10.000 – 500.000 kcal/h
1.000 – 6.000 l/h
Contact Fluid Dynamics for detailed information.