Turn key capabilities

Developing Complete and Complex Project

With roughly 70 years’ experience and thousands of equipments sold all over the world, many with complete systems supplied to the main Biopharmaceutical and Cosmetic industries for the production of any type of product, Olsa has the competence and the capability to partner its customers in the development, design, manufacturing and validation of complete complex systems for any solid, semisolid and liquid product, including aseptic processing

 

Technical description:

The key point of any production process equipment or complete system in the biopharmaceutical industry is to grant the expected constant quality of the product at the end of the production process

For this reason today Pharmaceutical Customers look for a reliable supplier to be a partner in the making of a complete plant

  • Those including proprietary and ancillary equipment, process components control instruments, fully automated, CIP skid and relevant structures
  • Supply includes proper project management, installation of all bulk materials, commissioning, start up
  • Safety during construction is considered as utmost important factor, as well as documentation for cGMP compliance

Olsa’s organization is characterized by:

  • Deep and continuously updated knowledge of the latest pharmaceutical regulatory
  • Strong engineering know-how and organization, as well as modern engineering tools and software
  • Purified water, water for injection and pure steam generation equipment construction and testing capability
  • Storage and distribution loop components and piping construction
  • On site equipment and loop components & piping installation capability, with internal installation teams and skilled yard managers
  • Experienced start up engineers
  • Capability in terms of Design, Installation & Operation Qualification, as well as a Performance Qualification support

Based on all of that, Olsa is in the position of being a solid and reliable partner for the realization of any complete pure water pharmaceutical system, anywhere in the world

 

On customer request Olsa is able to act as a turn-key supplier for the whole process area for sterile and non-sterile liquids production factory, including:

  • Basic and detailed engineering for complete preparation system
  • SVP, LVP, Eye drops, Syrups, Aerosol, Cream and Oinment equipment construction and testing capability
  • Storage and distribution loop components and piping construction and purchasing
  • Preparation areas, including preparation reactors, mixing, sterile filtration, product distribution
  • On-site equipment and loop components & piping installation
  • Start up and SAT
  • Full Design, Installation & Operation Qualification execution, as well as Performance Qualification support

Site installation

Manufacturing and installing capabilities

 

Over the years, Olsa has developed the capability of manufacturing and installing, on customer site, full systems for the production and storage of liquid, semi-solid and solid forms

Olsa’s site installation organization includes:

  • Internal fully certified installation teams, including certified welders and site assistants
  • Very experienced yard managers, with many years of involvement in the Company as site supervisors and in important installations throughout the world
  • Complete ranges of installation tools including welding machines, bending, cutters, etc.
  • Specific procedures, fully integrated in Olsa Quality Management Plan, to grant the quality of the site installation in full compliance with the latest international regulatory

Thanks to all of that, Olsa is ready to take full responsibility for the site installation of complex projects in any area of the world, being totally independent and self-sufficient, and without any special assistance from the Customer

Automation

Wide range of configurations

Olsa equipment and systems are equipped as standard with PLC controller with HMI (Human Machine Interface). A wide range of configurations are available, based on the use of widely applied brands and models of PLC such as Siemens, Allen Bradley, Schneider Electric, Mitsubishi, etc.. The HMI operator panel can be selected according to customer specific needs. All the PLC controllers are standardly able to be connected to factory supervisory systems, via the most common interfaces like Ethernet, Profibus, control net, device net and remote connection via modem

The whole Software development and implementation is performed by Olsa automation department in accordance with the latest edition of GAMP. The main activities of the Automation Department are:

  • Software design
  • Software development
  • Software organization
  • Software documentation
  • Testing
  • Installation
  • Filing

Upon request, Olsa can even provide complete SCADA systems for the supervision and control of the Processes Systems

SCADA systems are developed based on iFIX, RSView 32, Win CC, etc. and are realized in strict accordance to 21 CFR part 11 requirements

Olsa can offer a wide range of services related to validation thanks to the full support of its sister Company DOC, specialized in many functional areas

cGMP COMPLIANCE & VALIDATION AREA

MASCO cGMP Compliance & Validation area organizes and develops validation activities with the “Validation Life-Cycle Approach”, which sees Validation as a traceable and documented evidence for all the activities developed during Life-cycle systems, from the user requirements definition up to the validation maintenance during the routine operation of the system

Olsa and DOC can together organize and implement the following activities:

  • Training program of personnel on validation and GMPs related topics
  • Validation master plan preparation
  • User requirements specification preparation (URS)
  • Functional & design specification preparation (FDS)
  • Design qualification (EDR: Enhanced Design Review)
  • Validation protocols preparation, “Site” tests execution & validation reports preparation for:
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Performance Qualification (PQ)
      • Process Validation (PV)
  • Planning & Execution of instruments calibration at final user site
  • Computerized control system validation as per GAMP and 21CFR part.11 requirements

Engineering

Make it possibile


Olsa provides the following services to its customers:

Consulting on process and equipment, feasibility studies, preliminary and detailed designs

In addition to regulatory compliance issues, state-of-the-art technology and expertise are critical to our clients. Such technology and knowledge come from a good engineering design made of:

  • Knowledgeable technical department
  • Wide production process knowledge and competence
  • Specific engineering “know-how”
  • Totally updated project, in compliance to cGMP standards
  • Up-to-date engineering tools

Olsa is able to act as a turn-key supplier for the whole process area for the production of all the main Biopharmaceutical and Cosmetic products from the aseptic liquid forms to the non sterile ones and semisolid, both sterile or bioburden controlled

Our activities include:

  • Basic and detailed engineering for the complete preparation system
  • Reactors, Preparation tank, CIP/SIP station, Bioreactors, Mixer, Homogenizer, Dynamic and Static equipment construction and testing capability
  • Storage and distribution loop components and piping construction and purchasing
  • Preparation areas design and manufacturing including sterile filtration, product dispensing and distribution
  • On-site equipment and loop components & piping installation
  • Start up and SAT
  • Full Design, Installation & Operation Qualification execution, as well as Performance Qualification support