"CSPE process cuts delivery times and accelerates the commissioning of pharmaceutical systems"
Comprehensive Scientific Process Engineering
CSPE Process cuts Delivery Times and Accelerates the Commissioning of Pharmaceutical Systems
As short a time as possible between placement of the order and the start of production: a priority for both the manufacturers and operators of pharmaceutical systems. As a supplier of overall systems, with CSPE, Optima Pharma has created a comprehensive, systematic concept that supports this goal and leaves nothing to chance in the entire process.
The aim is to deliver new products to the market as quickly as possible. This does not only apply to pharmaceuticals. But for pharmaceutical manufacturers, it is particularly important to keep the time between completion of the approval phase and putting a product on the market to a minimum: on one hand because of the lengthy development times and high development costs, on the other as international competition is increasingly keen. The long delivery times that arise in many areas of plant engineering when capacities are stretched to their limits are a serious problem in the pharmaceutical industry.
At the same time, increased requirements are placed on the flexibility of the system. It needs to be able to handle smaller batch sizes, and various containers, for example syringes, vials and cartridges, need to be filled on one system. This makes systems increasingly complex – and normally, it would make the entire process, from design and engineering to the actual construction of the plant right through to validation, even lengthier.
To Media Fill in Record Time
A fast and safe production start
Optima Pharma has the solution for this problem: Comprehensive process engineering following a scientific approach allows the realization of short delivery and commissioning times together with quick qualification of the system and a facilitated official audit. The pharmaceutical system manufacturer calls this approach “Comprehensive Scientific Process Engineering,” or CSPE for short. It combines tried and tested, accelerated concepts and procedures such as digital engineering, simulation, virtual reality and integrated FATs. This minimizes so-called “time thieves.” In this way, the “media fill,” proof that sterile products can be produced on the finished filling system, is successfully carried out in record time.
- Reduced time between odrder placement and production start
- Faster qualification with the iFAT
- Faster requalification on-site
- Accelerated start-up at the customer's site
- Complete test of the machine during the iFAT
- Scientific based qualification support
- Support during FDA or other authority audits with verifiable simulation processes
Spot-on “first shot” thanks to advance Virtual Mock-Up
Consistently exploiting the potential of digital engineering
„In the course of CSPE, we are using the full potential
that digital engineering offers.“
As a further example of an application where simulation has already been successfully used, Breu mentions the process of freezing vials on a freeze-dryer shelf. Following modification of the shelf design compared with a previous system, the customer wanted proof that a newly designed side guide had no negative effect. Breu recalls: “We were able to prove that a firmly installed guide rail actually had a positive effect on the freezing process.” In this way, the customer received a welcome design modification without the need for time-consuming test constructions.
Reliably qualified with integrated FAT
Comparing your results with reality is essential if you are aiming for continual improvement
And with realistic system qualification as part of the iFAT, the process comes full circle. The engineering department receives direct feedback on the accuracy of the previous simulations and thus input for further optimization of the simulation models.
Turnkey plus CSPE = faster time-to-market
The operators of systems will see the positive effects of CSPE in many areas
- Advance virtual mock-ups and training via digital engineering
- Qualification via iFAT, quick re-qualification at the point of use
- Faster, low-risk commissioning on the user’s premises
- Scientific approach provides support during official audits
- Cuts time between placement of the order and start of production
- Minimization of risks before the start of the design phase