Clean Services

GMP / particulate and microbiologically controlled

The manufacture of medicinal products is subject to strict regulations and hygiene standards. In particular, the revision of the GMP guidelines, Annex 1, focuses on the establishment and implementation of a Contamination Control Strategy (CCS) for manufacturers of sterile medicinal products as well as non-sterile forms. The professional cleaning and disinfection of the production environment in accordance with written programs is an essential part of this strategy.

comprei offers these cleanroom services:

1. Maintenance cleaning - the continuous cleaning and disinfection of production and laboratory rooms by sensitized cleanroom cleaning staff.
   Optionally, we can work with you to adapt the cleaning processes to improve quality by means of process analysis and risk assessment. This includes the selection of suitable cleaning agents and disinfectants as well as the definition of suitable procedures.
2. Special cleaning before qualification and requalification of cleanrooms and after shutdowns

• Technical maintenance work (filter replacement, conversions, etc.)
• after unforeseen events such as fire, flooding, etc.
• in the event of microbiological deviations
• when commissioning new lines (plants for aseptic filling of medicines, sterile areas of hospital pharmacies and compounding centers...)

The concept of special cleaning is always developed together with you after analyzing the initial situation (incl. inspection) and precisely defining the target condition.

Personnel qualification

After completing onboarding, every member of our service team is included in the ongoing qualification program. This program ensures that the necessary professional competence, awareness and skills are available at all times.(Training in accordance with ISO 21001 and ISO 29993 standards)

Employees of our service teams benefit from the same quality of training that renowned companies purchase from us.

The focus of continuous qualification is on

• Recognizing contamination potential
• Methods for avoiding contamination
• Awareness of critical work areas
• Knowledge and understanding of the relevant standards (ISO 14644, VDI 2083, GMP guidelines)
• Cleaning and disinfection techniques for cleanrooms and controlled areas
• Suitable wiping techniques for different surfaces
• Special features of room cleaning (ceiling, walls, floor)
• Handling of cleanroom cleaning equipment
• Simulation of typical situations and finding solutions
• Visualization of contamination and its carryover

The service is performed and documented in accordance with the operator's standard operating procedures (SOPs). If these are not yet available, the internal comprei standard documents are used.

Component cleaning and packaging in a certified cleanroom—including ISO 5 environments when required

Components often do not meet the cleanliness standards required for use in controlled environments—and thus often fail to meet the requirements of downstream processes or customers.

We ensure that your components are ready for immediate further processing or use: cleaned, packaged according to your specifications, and ready for immediate use.

Applications:

• Machinery and Plant Engineering
• Semiconductor and High-Tech Industry
• Suppliers with cleanliness requirements, e.g., the aerospace industry, the optical industry, and precision engineering

Collaboration Process:

1. Alignment of Requirements and Components
2. Cleaning Under Cleanroom Conditions
3. Packaging in accordance with the requirements
4. Documentation and Handover