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Pharma and Biotech
Reliable processes for maximum production safety

Smart systems for sterile vial bulk filling

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Filling and packaging sterile liquids in vials and infusion bottles can be very demanding on system technology. We help you meet these challenges with individually designed, platform-based machine solutions – and, of course, constant communication.

Good to know: Optima offers perfectly integrated filling lines, isolators and freeze-dryers as turnkey solutions from a single source.

Product group of different vials
Not many companies are likely to know more about sterile vial filling than we do. Except you, of course.

One thing we know for certain: You often encounter time and budget challenges with filling and packaging high-quality pharmaceuticals in vials and infusion bottles. With your input, we will design the ideal solution for your requirements. The time-to-market must be short and product losses minimal. We repeatedly demonstrate our expertise as a turnkey partner in system design with the successful implementation of complex vial systems, complete with isolators and freeze-dryers.

We utilize the Comprehensive Scientific Process Engineering (CSPE) approach to ensure your product gets to market quickly and safely. During operation, smart innovations minimize process and system downtime, as well as reducing product losses to a maximum of one object per batch. Digital components and services also guarantee uncompromising quality, maximum safety and optimal flexibility.

The process steps for filling vials and infusion bottles
The process steps for filling vials and infusion bottles
Pharma machine for filling vials and infusion bottles
1. Washing
2. Sterilizing
3. Filling
4. Closing
5. Freeze-drying
6. Magazining
7. Isolator
Pharma machine for filling vials and infusion bottles
1. Washing
Detailed image of the vial washing process inside a pharmaceutical machine

The first step is to clean your vials and infusion bottles in fully automated washing machines – available with optional ultrasonic pre-treatment. Single or multi-point grippers transport the products in either intermittent or continuous motion. Special designs can reduce your water consumption by up to 45%.

Benefits:

  • Effective and thorough cleaning
  • Intermittent or continuous motion
  • Reduced water consumption
2. Sterilizing
Sterilization process step within a pharmaceutical machine

After the glass containers progress through the washer, they proceed to the sterilization tunnel where they are sterilized and depyrogenized. From cleaning and sterilization to sterile filling, all Optima systems are part of a complete aseptic filling line that provide a continuous process in cleanroom conditions.

Benefits:

  • Sterilization tunnel for every application
  • Gentle heating of the objects
  • End-to-end process under cleanroom conditions
3. Filling
Vial filling process

Whether viscous or water-like liquids, we offer the appropriate filling solution for every product type and batch size. If the right solution isn't already available, we will work with you to develop it. Our experience with a wide range of applications,  like biotech, biosimilar, generic medicines, vaccines, blood plasma or oncology give us unique knowledge to create a solution for your needs. Available filling technologies include rotary piston pumps, peristaltic pumps or time pressure filling systems. Additionally, other filling systems can also be integrated.

Benefits:

  • Depending on the product: Vacuum or sensor filling, gassing etc. 
  • 100% in-process control as standard
  • Filling path optional with single-use or CIP/SIP
  • Integrity tests such as PUPSIT are available (for Annex-1-requirements)
  • Safe rake transport, quick format change
     
4. Closing
Process: Vial closing

Our systems close your vials and infusion bottles fully automatically with all standard closures. We employ technology that minimizes product loss to maximize yield. Other technologies ensure quality; for example, gassing during closing ensures a residual oxygen content of less than one percent when filling highly sensitive products.

Benefits:

  • Compact design
  • Fully automated closing
  • All standard closures
  • Minimal product loss
5. Freeze-drying with filling and unloading
Freeze dryer loaded with vials

The fifth step, if required by the product, is freeze-drying, extending the shelf life of the ingredients. As a turnkey provider, we connect this step seamlessly to the filling line – for optimal efficiency in your production process. Our freeze-dryers are scalable for every production quantity, from small clinical batches to large commercial batches. We also offer loading and unloading systems tailored to your freeze-drying requirements - from manual to fully automatic systems.
 

More information on freeze-drying from Optima Pharma
6. Magazining
Detailed image of the magazining process step in a pharmaceutical machine

At the end of the process chain, the system collects the objects in a magazine. The injection and infusion bottles are magazined by the system in the exact quantities and hexagonally offset. The magazining system can fill two or four magazines alternately. This means that magazine changes take place without stopping the machine.

Benefits:

  • Magazining in exact quantities
  • Magazining with hexagonal offset
  • Magazine change without stopping the machine
7. Isolator
Pharmaceutical machine view with isolator

Containment solutions such as isolators supplement our turnkey portfolio for vial and bottle filling. The isolators can be combined with any type of pharmaceutical system.
 

More information on isolators from Optima Pharma
OPTIMA pharma | Experts for aseptic filling
Do you have questions or would you like to discuss your specific requirements with Optima's experts?
OPTIMA pharma | Experts for aseptic filling
OPTIMA pharma
+49 791 9495 - 0 customer.info@optima-packaging.comWrite e-mail
OPTIMA pharma | Experts for aseptic filling
OPTIMA pharma | Experts for aseptic filling
OPTIMA pharma
Good to know
Wide range of applications

Whether start-up or large corporation: We partner with biotech and pharmaceutical companies all over the world - designing systems for filling products in clinical studies, as well as small, medium and large commercial production batches. With our holistic understanding, experience and ingenuity, we find solutions for highly available, flexible and process-safe handling of your products. Turnkey systems from Optima Pharma fill blood plasma products, cell and gene therapy products, vaccines, high potency products, biosimilar, generic pharmaceuticals, biotech and veterinary medical products.

Blood plasma: doctor treats patient

Blood plasma

Because every drop counts: Rely on Optima’s smart solutions for filling blood plasma products – safety and productivity combined.

Cell and gene therapy

Highly sensitive cell and gene therapy products require flexible and automatable solutions for safe production and filling.

Person being vaccinated

Vaccines

Time is often a critical factor in vaccine filling processes. Optima speeds up the filling and packaging of sterile liquids with innovative systems.

High potency drugs

A complete overview is essential when filling and processing high potency pharmaceuticals – which is why we create comprehensive processes for maximum safety.

Doctor drawing up syringe

Biotech and biosimilars

For challenging production requirements, we offer holistic process knowledge for aseptic filling, including maximum product protection.

Technology with added value For maximum product yields

Biopharmaceuticals are often expensive to obtain and produce. Therefore, we  analyzed and restructured the entire filling and packaging process. 

Whether re-dosing, re-stoppering and re-capping or 100% process control: A wide range of functions intertwine with one clear goal – maximum product yield and cost efficiency for you.

Detail picture of the filling process of a pharmaceutical machine
Technology with added value For maximum product yields

Biopharmaceuticals are often expensive to obtain and produce. Therefore, we  analyzed and restructured the entire filling and packaging process. 

Whether re-dosing, re-stoppering and re-capping or 100% process control: A wide range of functions intertwine with one clear goal – maximum product yield and cost efficiency for you.

Detail picture of the filling process of a pharmaceutical machine
Detail of a pharmaceutical machine transporting vials
Technology with added value

For maximum process safety

For companies that manufacture and fill products essential to life, production safety processes are a top priority. This is why Optima systems feature sensors and cameras to monitor production. We offer a wide range of inspection and monitoring technology to safeguard your product quality in every aspect.

Technology with added value

For minimal downtimes

Digital solutions from Optima provide an overview of your production at all times so you can identify potential for improvement, increase  availability of the system and receive direct support when needed. Optima developed the Intelligent Production Assistance Services (IPAS) to support you before and throughout the entire  production process.

Optima employee maintains a pharmaceutical machine with the help of AR glasses
The right system for any bulk vial filling process

We work with you to determine the ideal solution for your aseptic filling application – from semi-automatic systems for small batch sizes in R&D or clinical studies, to a high-performance system with up to 45,000 units per hour and filling capacity of 500 milliliters.

We offer a complete machine portfolio for bulk vial processing:

  • Washing machines
  • Sterilization tunnels
  • Filling machines
  • Closing machines
  • External washing machines
  • Labeling machines
  • Magazining machines/magazining units
Machine for vial filling
Whether small and compact …
Machine for vial filling
… or for large quantities
OPTIMA pharma | Experts for aseptic filling
Which system best fits your requirements? Contact us to discuss a system design that will drive your pharmaceutical production forward.
OPTIMA pharma | Experts for aseptic filling
OPTIMA pharma
OPTIMA pharma | Experts for aseptic filling
OPTIMA pharma | Experts for aseptic filling
OPTIMA pharma
+49 791 9495 - 0 Write e-mail
Success stories in aseptic filling - from and with OPTIMA
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Three Optima employees
Do you have questions or would you like to discuss your specific requirements with Optima's experts?
OPTIMA pharma | Experts for aseptic filling
OPTIMA pharma
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