Your goal
is our task

Expertise

Our know-how regarding process and faciilty design in the field of pharmaceutical, chemical and bioprocess technology is based on many years of practical experience both as operator and planner/project engineer or quality assurance.

We are happy to accompany you through all phases of your project:

Project Management

We advise and support you in setting up an appropriate project structure and in the further course of the project

  • Definition of project goals
  • Creation of project structure plans
  • Creation of milestone schedules and control
  • Budget planning and control
  • Project control, interface support in the course of the project after the award of contract up to commissioning and qualification

Concept Development – Conceptual Design

  • User requirements and process analyses
  • Feasibility studies and concepts based on your requirements
  • Elaboration of possible alternatives with clear statements on key technologies, costs and deadlines
  • Concepts for production systems, clean rooms, and air handling equipment
  • Hygiene zone and pressure levels
  • Concepts for production areas, personnel and material flows with corresponding airlocks
  • Concepts for air conditioning and ventilation technology
  • Planning of equipment with special ventilation requirements such as free working places, workbenches, and isolators
  • Clearly structured documents spanning the trades as a basis for further project phases
  • Planning of modification

Approval planning and preparation for award of contract

The planning takes into account the requirements of the essential quality, safety and environmental directives from the beginning

  • Preparation of tender documents (User Requirement Specifications – URS or other specifications)
  • Tendering and bid evaluation
  • Offer and technology comparisons
  • Decision analyses
  • Templates for approval applications

cGMP & EHS Compliance

Based on relevant standards and current guidelines and recommendations, we advise and work with you to develop the necessary measures to establish and improve compliance.

  • Status survey
  • GAP analyses
  • Risk analyses, preferably according to FMEA (Failure Mode and Effects Analysis)
  • Risk assessments according to ArbSchG (Occupational Health and Safety Act)
  • Contribution of many years of experience from GMP and EHS audits

cGMP-compliant documentation and qualification

Preparation of all necessary documents, according to current GMP requirements (Good Manufacturing Practice) in all project phases

  • Use of your templates or our standards
  • Review of supplier documentation
  • Support in all phases of commissioning and qualification by experienced employees

Design, planning and specification of process plants

We are specialized in technologies for the production of pharmaceutical, biotechnological products and active ingredients also under consideration of High Potent and Ex-requirements.

  • Weighing systems
  • Preparation systems for sterile and non-sterile liquid and solid products, also multiphase systems
  • Filling systems for sterile and non-sterile liquid products in injection bottles/vials, syringes or cartridges
  • Filling systems for sterile and non-sterile powdery products in injection vials/vials
  • Freeze-drying systems with automatic loading and unloading systems
  • High containment systems/barrier systems (isolators, cRABS, RABS, safety cabinets)
  • Cleaning and sterilization systems
  • CIP/SIP systems (Cleaning In Place/Sterilizing In Place)
  • Equipment washing machines (parts washers)
  • Autoclaves
  • Bulk solids processing, bio, and chemical process engineering
  • Bioreactors from laboratory to industrial scale
  • Chemical reactors from laboratory to industrial scale
  • Equipment for crushing and sieving, mixing, and dosing of bulk materials
  • Media supply and disposal
  • Pharmaceutical water systems: production, storage and distribution of pharmaceutical water and steam (Purified Water/Aqua Purificata, Water for Injection/WFI, Clean Steam)
  • Gas systems (such as compressed air or nitrogen)
  • Development of validation concepts
  • Wastewater systems (wastewater collection systems, wastewater decontamination or pretreatment)