Weiss Klimatechnik modernizes the production of HumanOptics AG with turnkey cleanroom technology as the general contractor

Fig. 2: The innovative intraocular lenses are manufactured using state-of-the-art production technology in the sub-nanometer resolution range.

Fig. 4: The artificial intraocular lenses from HumanOptics AG are produced under strict guidelines of the quality management system.

Fig. 1: Over an area of 700 m², the new cleanroom complex offers outstanding conditions for manufacturing in the high-definition sector. The climate control system by weisstechnik® ensures highly pure ambient conditions 24 hours a day, 365 days a year.

Fig. 3: The result of 15 years of experience: The Torica® by HumanOptics AG.

Fig. 5: The GMP-compliant monitoring system based on the weisstechnik® product S!MPATI monitors and documents the customer-specific parameters and ensures that cleanliness class, temperature, humidity, and room pressure are maintained at all times.

The production of implants for the eye world is a highly sensitive area. Even the smallest contaminants can cause significant damage. Therefore, production takes place under cleanroom conditions. To modernize the existing cleanroom technology and expand new production capacities, HumanOptics commissioned Weiss Klimatechnik with planning, construction, and qualification of a new cleanroom complex. All construction measures had to be carried out during ongoing production while strictly adhering to the EU GMP guidelines.

Quality requirements in a growing market

HumanOptics, based in Erlangen, is one of the innovation leaders and premium providers of eye implants, serving a rapidly growing market. The product range includes high-quality, serially manufactured standard intraocular lenses as well as custom-made solutions for individual requirements in eye surgeries. Development and production of all solutions take place at the Erlangen and Sankt Augustin locations. To prevent damage to the products and protect patients, HumanOptics applies particularly strict quality standards at every work step. This includes especially the production under GMP-compliant cleanroom conditions.

Modernization and expansion during ongoing production

Given the positive market development, HumanOptics aimed to comprehensively modernize the production area at the Sankt Augustin site and expand a total of 700 m² of GMP-compliant cleanroom space according to guidelines C and D. HumanOptics site manager Mario Sündermann explains: “We want to continue growing and open up new markets. At the same time, we aim for a new quality level with our manufacturing.” An explicit goal was also to obtain FDA certification for the American market. A particular challenge was that all construction measures had to be planned and executed in such a way that ongoing production was not affected.

Experienced partner for manufacturing conditions in medical technology

The specialist Weiss Klimatechnik was commissioned with planning, construction, and qualification of the cleanroom. They had to ensure that production could continue uninterrupted. Additionally, two differently functioning plant areas had to be considered. To enable this, an individual solution was developed with its own chilled water system in split design, coordinated filter-fan units, and a special building automation system. The air conditioning systems were designed as mixed air systems with outdoor and recirculated air components, ensuring the air supply for the new production areas. This maintains room air conditions such as temperature, relative humidity, room pressure, and cleanroom classification, taking heat loads into account.

Monitoring system supervises and documents critical parameters

To ensure compliance with legal regulations, industry standards, and customer-specific parameters at all times, the order also included a monitoring system. Based on the Weiss Technik software S!MPATI®, a GMP-compliant monitoring system was installed. This guarantees at all times that purity classes, temperature, humidity, and room pressure meet the legal quality requirements in production.

Implementation, results, and outlook

The detailed planning was followed by a four-stage implementation within 10 months. After dismantling the old facilities, the new production rooms were built. Subsequently, the climate control system was installed and also qualified by Weiss Klimatechnik. The ongoing operation of production could be maintained at all times. The new cleanrooms operate 24 hours a day, 365 days a year. The climate control system is dimensioned so that an area currently used as a warehouse can later be easily converted into a class D cleanroom if needed. This makes the new site particularly flexible and future-proof.

Site manager Mario Sündermann summarizes the project: “Our intention was to work with a competent partner who can deliver a turnkey solution from a single source and also guarantees after-sales service. Weiss Klimatechnik has implemented this excellently.”

Special features of the project:

• - Basic area 700 m²
• - Dismantling of old facilities in manufacturing
• - Continuous production during construction phase
• - Walk-in cleanroom cabin, quality class: EU GMP guidelines: C and D
• - Room conditioning 22 °C ± 2K
• - Relative humidity 40 – 60%
• - Compact chilled water system in split design
• - Special filter-fan units
• - Outdoor air dehumidification via second installed cooling circuit in the climate cabinet
• - Monitoring system S!MPATI® monitor
• - GMP qualification (DQ/IQ/OQ)
• - Microbiological spore count measurement
• - Complete EMSR and software development