Advanced Process Equipment for the Pharmaceutical Industry
For many years, HML Nosewicz has been manufacturing high-quality process equipment for the pharmaceutical industry, supporting both standard and highly specialized production processes. Over time, we have developed in-depth expertise in the specific requirements of pharmaceutical manufacturing, allowing us to confidently position ourselves as a trusted and experienced partner for this demanding sector.
Our solutions are designed to ensure maximum safety, sterility, and repeatability, in full compliance with international pharmaceutical regulations.
Pharmaceutical Compliance: FDA, PED and ASME Standards
All pharmaceutical equipment manufactured by HML Nosewicz meets strict quality and regulatory requirements in accordance with:
– FDA guidelines
– PED (Pressure Equipment Directive)
– ASME standards
By adhering to these internationally recognized regulations, we ensure that our equipment is suitable for GMP-compliant environments and meets the expectations of global pharmaceutical manufacturers.
Superior Surface Finish for Maximum Sterility
Pharmaceutical process equipment is defined by an exceptionally high finish of product-contact surfaces. To guarantee the highest level of cleanliness and sterility, HML Nosewicz applies the most advanced manufacturing and polishing technologies, achieving surface roughness values as low as Ra 0.01.
– This level of surface quality:
– Minimizes the risk of contamination
– Supports effective CIP and SIP procedures
– Ensures compliance with hygienic and sterile design principles
As a result, our equipment is ideally suited for critical pharmaceutical applications.
Certified Strength Calculations and Mechanical Integrity
To ensure operational safety and long-term reliability, we perform comprehensive strength and pressure calculations in accordance with internationally recognized design codes, including:
– AD 2000
– EN 13445
– ASME Section VIII, Division 1
These calculations verify the mechanical integrity of reactors, mixers, tanks, and heat exchangers, ensuring safe operation under defined process conditions.
High-Grade Materials and Full Material Traceability
HML Nosewicz manufactures pharmaceutical equipment using carefully selected stainless steels and alloys tailored to specific process and customer requirements. Commonly used materials include:
– 304L
– 316L
– 316Ti
– Duplex and super duplex steels
– Other specialized steels upon request
All components are sourced from reputable suppliers, ensuring consistent quality, reliability, and complete traceability throughout the production process.
Certified Materials According to EN 10204
To meet pharmaceutical quality standards, we use only materials with properties confirmed by certificates issued in accordance with EN 10204, including:
– 2.1
– 2.2
– 3.1
– 3.2
This guarantees full transparency, regulatory compliance, and documented material properties for every manufactured device.
Comprehensive Product Range for Pharmaceutical Processing
Our portfolio includes a broad range of pharmaceutical process equipment, designed for hygienic production, flexibility, and scalability. The HML Nosewicz offer includes:
– Vacuum-pressure and non-pressure reactors
– Homogenizing mixers
– Process mixers
– Powder mixers
– Tanks for internal transport
– Storage tanks
– Purified water systems
– Aseptic shell-and-tube heat exchangers
– Customized pharmaceutical vessels and equipment
All solutions are engineered to meet individual process requirements and validated for pharmaceutical production environments.
Trusted Partner for Pharmaceutical Manufacturing
Thanks to long-term experience, advanced engineering expertise, and strict adherence to pharmaceutical standards, HML Nosewicz is a reliable partner for manufacturers seeking high-quality pharmaceutical process equipment. Our solutions combine precision engineering, certified materials, and modern production technologies to support safe, compliant, and efficient pharmaceutical manufacturing.
