Technical projects & advice

Risk Analyses

THERAXEL carries out tailor-made risk analyses for you using the tools described in ICHQ9 or related models.

In order to perform these risk analyses, depending on the context, we use, among others, the following regulatory texts:

 

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH Harmonised Tripartite Guideline – Quality Risk Management Q9
  • Eudralex Volum IV Good Manufacturing Practices, Partie I, Chapitres 3 et 5, Partie III , Annex 1 Production of Sterile Medicinal Products and Annex 15 Qualification and Validation
  • ISO 22716: 2007 – Cosmetics Industry – Good Manufacturing Practices (GMP) – Guidelines for Good Manufacturing Practices
Attention

Services

  • Drugs Manufacturing Zones
    (Receiving storage location, sampling, weighing, manufacturing, packaging, dispatch location and control laboratories)
  • Cosmetic products Production Zones
    (Receiving storage location, sampling, weighing, production, packaging, dispatch location and control laboratories)
  • Quality Control Laboratory
  • Laboratory animal houses

Types of risk analysis

  • Cross-contamination 
  • Particulate, microbiological and pyrogenic contamination: Contamination Control Strategy
  • Managing viral and microbial contamination in laboratory animal houses

THERAXEL is here to provide you with the necessary support for all risk analyses, i.e. including defining continuous improvement actions and assisting in their implementation.

Business sectors concerned

  • Sterile and non-sterile pharmaceutical industries
  • Cosmetic industries
  • Medical Device Industries
  • Microelectronics industries
  • Animal Facilities
  • Hospitals

Services

  • Overall management of processes: development and drafting of procedures, drafting of protocols, carrying out tests, drafting of reports, etc.
  • Qualification of cleaning systems
  • Validation of equipment Cleaning: Drafting of protocols, carrying out tests and writing associated reports
  • Bio-cleaning of premises
  • Validation of airborne disinfection processes

THERAXEL has a proven track record in the cleaning and disinfection sector and wishes to continue to offer its customers the benefit of its experience gained in this field in a number of industrial and service sectors.

Cleaning and disinfection

Premises and Equipment

THERAXEL is here to support you for the overall management of all the cleaning and disinfection processes of your premises (Bio-cleaning processes) and of your equipment (process qualification and cleaning validation).

To carry out these advisory projects, audits and technical assistance, we rely on our historical know-how (expertise in the products used, consumables and associated processes) and on the skills of our team of confirmed experts.

 
Nettoyage

Operational quality assurance

THERAXEL carries out operational projects for you relating to the implementation and monitoring of environmental controls in your Controlled Atmosphere Zones and is responsible for any investigations in the event of chemical and microbiological contamination for the processes in place.

In order to perform these mission, we use the following regulatory texts : 

 

  • Eudralex Volum IV Good Manufacturing Practices, Partie I, Partie III ,Annexe 1 Production of Sterile Medicinal Products and Annex 15 Qualification and Validation
  • ISO 22716 : 2007 – Cosmetics Industry – Good Manufacturing Practices (GMP) – Guidelines for Good Manufacturing Practices 
  • FDA 21CFR Parts 210-211 and Guidance for Industry « Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice »
  • PDA Technical Report no. 13,, Fundamentals of an Environmental Monitoring Program
  • USP〈1116〉Microbiological Control and Monitoring of Aseptic Processing Environments
Rouages

Services

  • Drugs Manufacturing Zones
    (Receiving storage location, sampling, weighing, manufacturing, packaging, dispatch location and control laboratories)
  • Cosmetic products Production Zones
    (Receiving storage location, sampling, weighing, production, packaging, dispatch location and control laboratories)
  • Animal Facilities

Types of risk analysis

  • Management of Environmental Controls in your ZACs:
    • Definition or optimisation of your environmental monitoring strategies (location, frequency, choice of media and incubation)
    • Assistance in the creation and monitoring of associated trend analyses
  • Operational investigations following chemical and microbiological contaminations:
    • Non-compliant Media Fill Tests
    • Non-compliant environmental controls
    • In-process controls on your bulk, intermediate and/or finished products

THERAXEL makes its entire team of experts available to you to find a solution to the contamination of your batches as quickly as possible and allow you to decide what to do with the products affected.

Industrialisation

Premises and processes

THERAXEL assists you in the development of new premises, in the implementation of manufacturing processes and participates in the Quality management throughout the creation of new production premises or Revamping actions.

To carry out these technical assistance projects, we rely on the skills of our team of experts who are confirmed experts in their respective fields of activity (process control, Quality Control laboratory activities, Biotechnologies, laboratory animal houses, contamination control, etc.) and on our reference partners.

THERAXEL is committed to working alongside you in the field to make your new industrial projects an operational and quality success within the deadlines set.

Concerned Manufacturing Zones

  • Drugs Manufacturing Zones
    (Receiving storage location, sampling, weighing, manufacturing, packaging, dispatch location and control laboratories)
  • Cosmetic products Production Zones
    (Receiving storage location, sampling, weighing, production, packaging, dispatch location and control laboratories
  • Animal Facilities

Services

  • Assistance in the design of a ZAC:
    • Review of P&IDs (Piping and Instrumentation Diagrams)
    • Participation in the development stages in association with cleanroom designers
  • Quality management when setting up new production areas or when revamping an existing area:
    • Supervision of service providers
    • Definition of qualification / validation strategies
    • Management of equipment qualification operations
    • Management of process validation operations
  •  

Services

  • Cleanrooms for Healthcare industries
  • Operating theatres, Recovery rooms, Sterilisation rooms…
  • L2, L3, L4 laboratories
  • Sampling and weighing box
  • Laboratory animal houses

Tests performed

  • Particle counts
  • Recovery or decontamination time
  • Air volume flow rate
  • Filter integrity and efficiency (Emery test) or particle counter filter scanning
  • Differential pressure
  • Air flow study (photography, film or diagram)
  • Airborne contamination
  • Surface contamination
  • Air speed / Laminarity
  • Temperature and relative humidity
  • Leakage tests / room leakage testing
  • Study of the accuracy and representativeness of the probes connected to a CTMS (temperature and humidity)
  • Brightness and sound flow measurement
  • Fluid control (compressed air, nitrogen…)

Cleanroom and clean air qualification

THERAXEL assists you in controlling the contamination of your cleanrooms via a qualification programme implemented in accordance with current standards and by drafting IQ, OQ and PQ protocols/reports.

 

For checking controlled atmosphere areas, we use the current standards in force:  ISO 14 644-1 (particle counting) and 14644-3 (physical measurements, Emery test, air flow study…) ISO 14 698-1 and 2 (microbiology of air and surfaces), GMP (pharmaceutical sector), NFS 90-351 (hospital sector) or a protocol subject to a client-supplier agreement.