Aseptic Pharma Solutions

CONTAMINATION CONTROL STRATEGY (CCS)

To implement a contamination control strategy (CCS) it is required a great knowledge about the aseptic process and the operations conducted as well as having a good overview of the activities carried out in the manufacturing plant.

Alongside your team, we can help you develop a Contamination Control Strategy applied to all your operations.

We can conduct a thorough audit to detect the weak spots of your Contamination Control Strategy and prepare it to comply with the health authority’s expectations.

And of course, we can create a CCS document which is compliant with the current regulations (from August 25th 2023, Annex I of the European GMPs).

FACILITIES AND CLEAN ROOM DESIGN CONSULTANCY

We can help you properly design your facilities and clean rooms to make sure the procedures and practices carried out in them are safe and comfortable for your employees. We know a faulty design can result in inefficiencies and bad practices that will be sustained during the facilities’ entire lifetime, or that will require a huge human and economic effort to correct them.

We design the rooms taking into account all the personnel and material flows, the cleaning and gowning, and the Standard Operating Procedures that will be carried out in them.

• Cleanroom distribution and classification
• Materials flow
• Gowning and personnel flow
• Cleaning and disinfection

SOPs CONSULTANCY AND CREATION

We can provide guidance in the design of the Standard Operating Procedures in your facilities to maximize the safety of your products and the comfort of your users.

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

HEALTH AUDITS PREPARATION

Over the years, we’ve successfully passed a great number of audits both oral and sterile, carried out by different health authorities such as:

• FDA (Food and Drugs Administration)
• EMA (European Medicines Agency)
• AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)
• KFDA (Korea Food and Drug Administration)
• ANVISA (Agência Nacional de Vigilância Sanitária)

We will carry out a preliminary audit, propose you an action plan on how to improve your business to meet the standards, and we can even train your employees to make sure they can face a health audit with the greatest guarantee of success.

VALIDATIONS

Together with our partners, we can coordinate and execute any kind of validation plan.

• Thermal
• SIP
• Garments life cycle
• Aseptic process
• Cleaning and disinfection