July 1, 2022

OPTIMA pharma at ACHEMA 2022 in Frankfurt

CSPE Center II
CSPE 2.0 for turnkey success

 

Reaching the goal faster with CSPE 2.0: At ACHEMA, Optima Pharma will present its successful concept for implementing complex turnkey projects consisting of a filling and capping line, isolator and freeze dryer to achieve safe production starts in less time. In the EXPERT ZONE, the mechanical engineering company will also present new trends in isolator technology, solutions for alternative refrigerants in freeze-drying, for cell and gene therapies, and for highly active ingredients. The advantages of comprehensive digitalization and the highly flexible OPTIMA MultiUse machine concept are further topics. You will also gain an insight into the holistic climate and environmental strategy for sustainable solutions in the pharmaceutical production of the future.

With CSPE 2.0, Optima Pharma presents the next development stage of the successful process in the EXPERT ZONE. CSPE 2.0 facilitates greater system integration and complex turnkey projects will succeed in a shorter time. A visible sign of this is the recently opened CSPE Center II (Schwäbisch Hall) with space for filling and capping equipment, isolators and, for the first time, freeze-drying equipment as a complete system from a single source. As a further novelty, Optima Pharma can carry out extended qualification measures in-house, including essential parts of the cycle development. Once again, this significantly reduces the time required between installation and start of production at the customer's site. The process presented at the ACHEMA also includes process simulations of the entire plants while they are still being designed, all the way to integrated factory acceptance tests (iFAT) at the CSPE Centers. At this point, complex turnkey projects have already been comprehensively tested under realistic conditions.



Wide range of digitization, flexible multi-use solutions up to high-performance applications

Today, digital technologies are an indispensable part of highly efficient fill & finish processes. Optima Pharma will present its comprehensive digitalization portfolio - the Intelligent Production Assistance Services (IPAS) - in the EXPERT ZONE. The multifaceted solutions include, for example, the continuous analysis of machine data and dashboard evaluations to detect performance fluctuations at an early stage. Predictive maintenance, which avoids unplanned machine downtime, is also part of this. However, if service is required, the fastest troubleshooting can be carried out remotely with secure, digital access. Optima Pharma's IPAS portfolio also includes augmented reality solutions to visually guide the plant operator's service staff through maintenance procedures and support them with information in data glasses. Flow and other simulation methods are used in design. Virtual reality accompanies the realization phase, for example with virtual mock-ups in Optima's Digital Innovation Center.

Premiere: The unique MultiUse machine series has been completed. The latest generation of OPTIMA MultiUse machines processes up to 24,000 containers per hour. For the first time, Optima Pharma offers machine solutions with identical functions from the laboratory to the high-performance range. That means processes can be transferred one-to-one right through to high performance. This includes, for example, product-saving functions such as re-dosing and re-capping, which prove their worth with higher-value to very expensive medicines. The extremely high filling accuracy of the MultiUse machine concept is also maintained right up to the high-performance range. The flexibility of the MultiUse systems will also be a topic in the EXPERT ZONE: Not only can container types including syringes, vials and cartridges be processed largely without format parts, different processing paths can also be integrated into a machine system. For example, a path for ready-to-use containers (RTU) can be provided in parallel with a path for bulk containers. In addition to a path for processing liquids, a freeze-drying path can also be used. Part of the MultiUse system is a sophisticated robotics concept that makes targeted use of the strengths of different robot types, for example to compensate for potential empty positions when renesting containers into trays.


Efficiency from the insulator cycle development, solutions for alternative refrigerants

Innovations in isolator technology will also be discussed in the EXPERT ZONE. Metall+Plastic, a subsidiary of the Optima Packaging Group, will be presenting a new process for cycle development using enzyme indicators, which offers advantages in addition to the process using biological indicators. The DECOpulse® decontamination system is characterized by particularly homogeneous H2O2 distribution and evaporation even at room temperature. How shorter cycle times can be achieved with it is also shown. In the field of pharmaceutical freeze drying, the EXPERT ZONE focuses on alternative refrigerants that take into account current European and international legislation. Whether air refrigeration, LN2 or cascade systems, Optima Pharma offers future-proof systems and advises customers on the selection, depending on the pharmaceutical application scenario and infrastructure requirements. Our freeze-drying specialists will also provide information on empirical values and comprehensive tests with cascade systems and, as a further highlight, on the test option with a Mirai air-cooling system. This will be available for customer testing at Optima Pharma from the fall of 2022 with a freeze-drying chamber of medium production size.


Technologies for new types of active ingredients, maximum safety for highly active ingredients

Pharmaceutical innovations like cell and gene therapies require new approaches to sterile processing. In close partnership with leading clinics, Optima Pharma has developed plant concepts for safe and also flexible processing solutions that significantly reduce the high costs of this new precision medicine. The EXPERT ZONE will show how automation concepts and robotics can significantly reduce the number of manual tasks, while increasing pharmaceutical safety.You will also learn more about Optima’s innovative solutions for the filling of particularly high-value, expensive drugs like viral vectors.

Many new active pharmaceutical ingredients are considered highly potent. In the EXPERT ZONE, Optima Pharma shows how specific plant concepts optimize the safety of the operating personnel while ensuring the integrity of the drug product, for example by special transport systems, effectively preventing potential carryover of active ingredients. In addition, the advantages of turnkey projects in the processing of highly active ingredients come into play when filling and capping technology, isolator technology and freeze-drying are designed as a complete system. Comprehensive plant simulations, coordinated interfaces, and integrated filter and washdown concepts for the filling line and isolators are examples of how process reliability can be increased and plants created as if from a single mold.

Sustainability is also becoming increasingly important in pharmaceutical mechanical engineering. With a holistic climate and environmental strategy, Optima Pharma ensures the lowest possible energy consumption both in the manufacturing and operation of the machines. The EXPERT ZONE will show how a pharmaceutical company can benefit from this in its environmental balance sheet.

Optima Pharma at ACHEMA 2022 in Frankfurt am Main, Germany.

(August 22-26, 2022): Hall 3.0, Booth A73



CSPE Center IIWith the CSPE Center II, inaugurated in May 2022, decisive prerequisites for deeper system integration have been created. Cycle development and testing of complete systems including freeze-drying are part of this. (Source: Optima)



Cameras inside the machineryComprehensive process control via high-speed video is one of many digitization services offered by Optima Pharma. (Source: Optima)



MultiUseMultiUse system with processing paths for liquids as well as freeze-dried products. The system also handles RTU containers (syringes, cartridges and vials in tubs or trays). Non-pre-sterilized vials pass through a washer and sterilization tunnel to the dispensing station. (Source: Optima)



DECOpulse®
The DECOpulse®bio-decontamination process generates extremely fine, atomized H2O2 spray mist and distributes it very evenly in the plenum. (Source: Optima)



Transport and robotics conceptsSpecific transport and robotics concepts from Optima Pharma offer flexibility as well as safe and highly efficient processing. (Source: Optima)

 

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