Aseptic process

Preparation of health authorities' audits

We have successfully passed, over the years, a large number of audits by health authorities, both oral and sterile.

• FDA (Food and Drugs Administration)
• EMA (European Medicines Agency)
• AEMPS (Spanish Agency for Medicines and Health Products)

We carry out a prior audit, propose an action plan for the improvements to be implemented, we can train your entire staff, and also establish the necessary organization to face the audit with the maximum guarantees of success.

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Consulting on the design of facilities and rooms

We help you design your facilities and cleanrooms correctly so that procedures and practices are safe and comfortable for your product and users.

Poor design causes inefficiencies and bad practices that are maintained throughout the lifespan of the facilities or require a great human and economic effort to correct them.

We design the cleanrooms taking into account the flows of personnel and materials, cleanliness and gowning, thinking about the Standard Operating Procedures that will be carried out in the facilities.

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Radiation sterilization (Beta, Gamma, and X-ray)

We offer validation, maintenance of process efficacy, and validation review services for your radiation sterilization process.

Sterilization technologies by electron radiation (beta), gamma radiation and X-rays are included, in accordance with the ISO 11137 guidelines in force, the applicable guidelines for the pharmaceutical, health and medical device sectors.

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Courses related to the pharmaceutical industry and the aseptic process

We offer specialized courses for regulated environments, focusing on Good Manufacturing Practices (GMP) and aseptic behavior in aseptic process manufacturing.

Our goal is to ensure that your organization's staff understand the reasons behind each of your procedures, thereby improving practice execution and therefore

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Consulting and drafting of Standrard Operating Procedures (SOPs)

We advise on the design of Standard Operating Procedures in your facilities to maximize product safety and user comfort so that they can be complied with.

• Materials flow
• Gowning and people flow
• Cleaning and disinfection
• Sterilization cycles
• Environmental monitoring (viable and non-viable particles)

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Validations

Together with our partners or yours, we coordinate and execute complete validation plans of all kinds, adapted to your processes, facilities and products, complying with regulatory requirements and the expectations of health authorities.

• Thermal
• Sterilization in Place (SIP)
• Garments life cycle
• Aseptic Process Simulation (APS)
• Cleaning and disinfection

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Contamination Control Strategy (CCS)

Contamination Control Strategy (CCS) requires knowledge of the aseptic process and the operations being carried out, as well as a global view of the activities of the manufacturing plant.

Together with your team, we help you develop a holistic Contamination Control Strategy (CCS) applied to all your operations.

We can conduct an audit to detect weaknesses in your CCS and prepare you to meet the expectations of health authorities.

And of course, we can help you prepare a Contamination Control Strategy document that complies with the regulations.

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