Setzen Sie als Pharmaplaner neue Standards in Ihren Projekten mit innovativen Edelstahloberflächen
- Efficient project partner: Stainless steel surfaces from BOLZ INTEC increase quality, safety and efficiency in production by minimizing particle adhesion. Project planning and design services complement our performance and make us a reliable and efficient project partner.
- Contamination-free production: Stainless steel containers, appliances and constructions from BOLZ INTEC are designed for use in industries with the highest standards of hygiene and cleanliness.
- Reproducible product quality: Flawless stainless steel surfaces from BOLZ INTEC reduce the risk of production downtimes & product recalls.
- Compliance with the highest standards: Stainless steel surfaces from BOLZ INTEC guarantee compliance with GMP and EHEDG.
More than 2,000 companies in 48 countries use stainless steel tanks & equipment from BOLZ INTEC
BOLZ INTEC stands for innovation, quality and precision in the manufacture of stainless steel containers, apparatus and constructions according to customer specifications. As an efficient and reliable project partner in the pharmaceutical, specialty chemicals and cosmetics industries, we create solutions that set standards in quality and hygiene; solutions that bring customers decisive economic advantages and increase the safety of products and production.
Our stainless steel containers and constructions are manufactured in accordance with GMP and EHEDG Hygienic Design guidelines. They are predestined for use in hygiene-sensitive industries. BOLZ INTEC's practical product development guarantees their uncompromising quality and safety.
15 of the 20 largest pharmaceutical companies worldwide are customers of BOLZ INTEC
Customers in the most sensitive industries rely on stainless steel tanks, apparatus and structures from BOLZ INTEC
Renowned project developers & planners: BOLZ INTEC has already worked successfully with some of them
Product portfolio of BOLZ INTEC
Pressure vessel
Stainless steel drums
Agitator tank
Special constructions
Reliable in every project phase
In close coordination with you, our project team takes on parts of your order. From the conception and design, to the punctual production and delivery of containers, apparatus and other components, right through to their commissioning. With our many years of experience and expertise in the processing of stainless steel, we can reliably offer you a wide range of services.
Design phase
- Needs analysis & requirements definition: Determination of the specific requirements of the project by the customer and definition of the project objectives.
- Feasibility study: Assessment of the technical and economic feasibility of the project, detailed project planning and budgeting.
- Concept design: Development of a design for the production plant/components, taking into account the specific requirements of the project.
- Design Qualification (DQ): Verification and documentation that the design of the equipment / components meets all specified requirements and regulatory requirements. BOLZ INTEC ensures that stainless steel tanks, equipment and other components meet the design requirements.
Implementation phase
- Ordering & production: Placement of orders by you and supervision of production according to the specific project requirements by BOLZ INTEC.
- Factory Acceptance Test (FAT): Inspection and acceptance of the finished system / components at the BOLZ INTEC factory to ensure that all specifications and requirements are met before the system is delivered to the installation site.
- Installation Qualification (IQ): Validation by BOLZ INTEC that the system meets the design specifications and has been installed correctly.
- Operational Qualification (OQ): Testing and verification of the system under operating conditions to ensure that it functions as planned.
- Performance Qualification (PQ): Validation of the entire system through test runs under real production conditions.
- Site Acceptance Test (SAT): Final inspection and acceptance of the system by the customer on site. BOLZ INTEC ensures that all components function properly and meet the specifications.
Operating phase
- Maintenance & support: Provision of maintenance and servicing services to ensure smooth operation of the system/components in the long term.
- Repair: Provision of services for the repair of systems / components.
Certifications
Quality assurance
DIN EN ISO 9001:2015-11
Certification
DIN EN ISO 3834-2:2021-08
Certification
DIN EN ISO 15085-2/CL1
Process tests
DIN EN ISO 15614-1 + AD-Merkblatt HP 2/1
Work tests
AD2000-HP 5/2
Specialist company
WHG §19/1
Operator tests
DIN EN ISO 14732:2013-12 + AD 2000 HP3
Pressure Equipment Directive
2014-68-EU/AD-2000 HPO
Intern. Welding engineers
DVS/IIW 1170
Welding tests
DIN EN ISO 9606-1:2017-12 + DIN EN ISO 9606-4:1999-06 for 1.4301 AISI 304, 1.4404 AISI 316L, 1.4435, 1.4539 + Hastelloy 2.4392 / C22
Module A2 Pressure vessel
Penetrant testing (PT)
DIN EN ISO 9712:2021-02
Services from BOLZ INTEC
Technical advice & design
Quality assurance
Refurbishing / barrel repair
Simoflex® drum wash
Superior stainless steel surfaces enable higher efficiency, lower costs & greater economy
Time savings in production
The use of stainless steel containers with optimized surfaces leads to significant time savings in the production process. By minimizing the build-up of materials, cleaning and maintenance times can be drastically reduced. This enables the containers to be reused more quickly and increases the overall efficiency of the production lines. In a production-intensive environment where time equals money, this time saving represents a significant economic advantage.
Reduced risk of production downtime
The reproducible quality of the stainless steel surfaces and the reduced number of defects minimize the risk of production downtime due to surface problems. This can lead to higher overall productivity and less downtime.
Reduction of production losses
Optimizing the container surfaces also minimizes the amount of product loss. Reduced adhesion means that more of the material produced is available for its intended use and does not end up as waste. This is a particularly important factor in industries where high-quality or very expensive materials are processed.
Improvement of product quality & product safety
Contamination-free production results in a higher quality end product. This is crucial in industries with strict quality and purity requirements, such as pharmaceuticals and food production, where purity and safety are top priorities. The use of optimized stainless steel containers can therefore also lead to an improvement in brand image and customer satisfaction.
Cost savings through more efficient cleaning
In addition to saving time, optimized surfaces also lead to a reduction in the costs of cleaning processes. Less build-up means less need for cleaning agents, water and energy. There is also less wear and tear on the containers themselves, which increases their service life and reduces the need for new purchases. In the long term, these savings in operating costs can make a significant difference to a company's profitability.
Longer container service life
The improved corrosion protection provided by the electropolishing process helps to extend the service life of stainless steel containers. Customers can thus reduce their costs for replacement investments and maintenance.
Case study 1
Increase in production capacity for sterile insulin preparations in compliance with the highest hygiene standards
Provision of customized stainless steel containers & apparatus for insulin production
Task
A leading pharmaceutical company specializing in the production of sterile insulin preparations was faced with the challenge of expanding its production capacity. The existing stainless steel containers and equipment could no longer meet the increasing requirements and strict hygiene and safety standards. There was an urgent need for a customized and reliable solution.
Implementation
As a project partner, BOLZ INTEC worked closely with the renowned engineering service provider to develop an optimal solution. By providing several hundred 200 liter ⌀ 560mm lidded drums and matching accessories made of high-alloy and low-ferrite stainless steel 1.4435 (AISI 316L), which were precisely matched to the specifications of the pharmaceutical company, BOLZ INTEC was able to make a significant contribution to the timely implementation of the new plant and the smooth start of production. The state-of-the-art welding techniques used and the final electropolishing ensured a high surface quality of ' 0.5 µm and a high level of product purity, which is essential for the production of sterile insulin preparations.
Result
The pharmaceutical company was able to successfully expand its production capacities and comply with all hygiene and safety standards. The customized stainless steel containers and equipment from BOLZ INTEC helped to increase production efficiency and ensure product quality. Thanks to the comprehensive services provided by BOLZ INTEC, including technical advice, TÜV inspections, hazardous goods approvals, logistics and extensive documentation 3.1, the project was implemented quickly, smoothly and reliably. This resulted in significant economic benefits and enabled the company to consolidate its excellent market position.
Switch to efficient production of hyaluronic acid with API
Task
An international cosmetics manufacturer specializing in the production of hyaluronic acid with active pharmaceutical ingredient (API) needed a solution to optimize its production processes. The existing production facilities were no longer efficient and frequent production interruptions led to considerable costs and delays. As part of the new solution, the high purity and stability requirements of the product had to be guaranteed.
Implementation
BOLZ INTEC was commissioned as the central project partner to design and install a suitable production line made of high-quality stainless steel components. BOLZ INTEC planned and designed the new system in close cooperation with a leading engineering service provider. The use of specially developed pressure vessels 20 liters ⌀ 560mm and piping with low particle adhesion ensured smooth and hygienic production, especially for viscous media. The components made of particularly high-quality chromium- and nickel-rich stainless steel 1.4539 (AISI 904L) provided the necessary corrosion and acid resistance and enabled product purity, which is crucial for the production of hyaluronic acid with API active ingredient.
Result
The new production line led to a significant increase in efficiency and productivity. The cosmetics manufacturer was able to reduce production costs and improve the quality of its hyaluronic acid products. The components supplied by BOLZ INTEC helped to exceed the industry's strict hygiene requirements and minimize production interruptions. Thanks to BOLZ INTEC's comprehensive services, including technical advice, TÜV inspections, hazardous goods approvals and logistics, the implementation of the project was faster and more reliable. The cosmetics manufacturer was able to strengthen its market position and achieve decisive economic advantages.
Case study 2
Optimization of production processes & improvement of product quality in the production of hyaluronic acid
Case study 3
Increasing production capacity & ensuring product purity in vaccine production
Replacing existing systems with modern stainless steel solutions
Task
A biotechnology company specializing in the production of vaccines was faced with the challenge of increasing its production capacity while ensuring the purity and quality of its products. The existing facilities could no longer meet the increasing requirements and strict quality standards.
Implementation
The use of stainless steel with added molybdenum 1.4404 (AISI316L) in areas in contact with the product and stainless steel 1.4301 (AISI304) in areas not in contact with the product ensured corrosion resistance and high chemical compatibility, which is crucial for the production of vaccines. The supplied V30/Ø315 bung drums and the matching accessories, e.g. asymmetric funnels and special funnels with individual angles, were specially manufactured to meet the high purity requirements of vaccine production and at the same time significantly increase production efficiency.
Result
The biotechnology company was able to significantly increase its production capacity and improve the purity and quality of the vaccines produced. The new stainless steel equipment from BOLZ INTEC enabled safe and efficient production, resulting in improved product quality and higher customer satisfaction. Thanks to BOLZ INTEC's comprehensive services, including technical advice, TÜV inspections and logistics, the implementation of the project was fast, smooth and reliable. The partnership with BOLZ INTEC gave the company a decisive competitive advantage in the biotechnology and pharmaceutical industry.
Materials for stainless steel containers & appliances
1.4301 (AISI 304)
Corrosion-resistant austenitic steel, versatile, good weldability, suitable for chemical and food applications.
1.4404 (AISI 316L)
Austenitic steel with added molybdenum for high corrosion resistance and good weldability, versatile in use.
1.4435 (AISI 316L)
Austenitic steel with increased molybdenum content and low ferrite content (' 3 %) for improved corrosion resistance and higher resistance to pitting.
1.4539 (AISI 904L)
Heat-resistant, high-alloy steel with increased chromium and nickel content, excellent resistance to acids and corrosion at high temperatures.
2.4602 Hastelloy C22
High-alloy nickel-chromium-molybdenum steel, excellent corrosion resistance to aggressive media such as acids, chlorine and oxidizing substances.
Special materials
In addition to the materials mentioned, BOLZ INTEC also processes other materials, depending on the customer's specifications and requirements.
Surfaces for stainless steel containers & appliances
Mill finish / 2B
Standard surface after rolling, uniform smoothness and roughness for a wide range of applications.
Brushed
Matt finish thanks to brushing, increased scratch resistance, ideal for aesthetic and functional applications.
Ground up to
Ra ' 0.4 µm
Fine, even surface, especially for applications with high purity requirements and aesthetic demands.
Electropolished up to
Ra ' 0.25 µm
High-gloss finish thanks to electrochemical polishing, maximum corrosion resistance and surface cleanliness.
OGF process up to
Ra ' 0.05 µm
Optimized Grind Finishing is a process developed by BOLZ INTEC and the University of Constance for minimal particle adhesion.
The Optimized Grind Finishing® process (OGF)
In the pharmaceutical, chemical and food processing industries, minimizing build-up in containers is a critical factor for efficiency and quality. The build-up of substances on the inside walls of containers can lead to increased cleaning effort, product losses and contamination. This costs money and ties up resources. Especially in industries where EHEDG (European Hygienic Engineering & Design Group) certification and hygienic design are becoming increasingly important, minimizing adhesion has become a critical factor.
Research carried out by BOLZ INTEC in cooperation with the University of Constance has shown that the way in which stainless steel surfaces are removed plays a key role in minimizing adhesion. Different grinding methods result in different adhesion behavior, despite the same Ra values, and the OGF process from BOLZ INTEC leads to a lower adhesion of particles.
Below is a scanning electron microscope image of the stainless steel surface after electropolishing and Optimized Grind Finishing®, as well as images of the surface texture roughness data and repeatability.
Easy cleaning & minimal adhesion
The Optimized Grind Finishing (OGF) process leads to a low adhesion of particles on the surfaces of the containers. This significantly improves cleaning efficiency and reduces the risk of contamination of product batches.
Reproducible surface quality
The OGF process enables reproducible surface quality. In contrast to conventional processes, in which variable factors such as manual contact pressure or the quality of abrasives play a role, the OGF process offers consistent surface quality.
Visual aesthetics and low number of errors
The stainless steel surfaces treated with the OGF process have an attractive appearance and defects in the surface structure are significantly reduced thanks to the fine and gentle removal process. This is particularly important in industries that place high demands on safety.
Improved corrosion protection
The electropolishing process not only improves the optical quality, but also results in chemical changes that lead to improved corrosion protection. This is particularly relevant for applications in chemical and pharmaceutical processes.
Reduced risk of batch contamination
The improvement in cleaning behavior through the OGF process leads to a significant reduction in residual dirt adhesion in the containers. This significantly reduces the risk of contamination between different product batches.
Applicability in critical industries
The process is seen as particularly advantageous for critical industries such as nanotechnology or biotechnology and pharmaceutical technology, where the highest purity requirements and the avoidance of contamination are of crucial importance.
Our project team looks forward to hearing from you
Do you have questions about our products and services or would you like advice from one of our competent employees?
Give us a call or send us an e-mail. We will make time for you and will be happy to call you back if you wish.
You ask, we answer
Edelstahl bietet eine hervorragende Korrosionsbeständigkeit, ist leicht zu reinigen und sterilisieren, und hat eine hohe Beständigkeit gegen Chemikalien und extreme Temperaturen. Diese Eigenschaften machen es ideal für die strengen Hygiene- und Qualitätsanforderungen in diesen Branchen und Projektierer-Planer.
Edelstahl ist ein extrem robustes und widerstandsfähiges Material, das eine längere Lebensdauer aufweist als Kunststoff. Es ist weniger anfällig für Risse, Verformungen und Abnutzung, was die Gesamtkosten für Wartung und Ersatz reduziert. Ideal für Projektierer-Planer.
DQ stands for Design Qualification. It is the process of checking and documenting that the design of the system or component meets all specified requirements and regulatory specifications.
OQ stands for Operational Qualification. This is the process of testing and verifying the system under operating conditions to ensure that it functions as planned.
Photo: On the shore of Lake Forggensee (Illasbergsee) @Allgäu GmbH, Nikolas SeymourI License: https://creativecommons.org/licenses/by-sa/3.0/de/