Enric Adserà

Interview with Enric Adserà, Project Manager at SherpaPharma

We interviewed Enric Adserà, Project Manager at SherpaPharma. Enric has a degree in Chemistry, Chemical Engineering and MBA from ESADE and is a recognized expert in the application of Environmental Monitoring solutions in the pharmaceutical Industry

1. Tell us a little about your beginnings at Tiselab

Prior to Tiselab, I worked for more than 20 years in the pharmaceutical industry in the development of analytical methods and subsequently as Quality Control Manager for a sterile products manufacturer. During this period, I acquired specific knowledge about pharmaceutical regulations (GMP, USP, EP, FDA) relating to critical areas such as Data Integrity, difficulties in information traceability and the lack of automation in the microbiology laboratory.

In view of my experience from the client’s perspective, four years ago I was offered the opportunity to lead the project to develop an environmental monitoring solution.

2. What does your current day-to-day work in the company involve?

My number one priority is to offer clients support, presenting the solution with personalised demonstrations, providing support in implementation activities and/or resolving doubts during PQ (Product Quality) control.

The rest of my time is devoted to coordination and management of the team. The team has been growing to offer clients support and develop new functionalities. This entails spending more time providing the different members of the team with assistance.

3. What are the biggest limitations facing laboratories and clean rooms when it comes to environmental monitoring?

In most companies, there is still a strong manual element to the process, with many manual annotations needed to ensure the complete traceability of the information related to the process.

This means that there are many stages in which non-compliance with data integrity requirements may occur: incomplete information, incorrect interpretation of existing data, errors in data transfer, etc. This can directly affect the quality of the information that appears on the environmental certificates or the environmental quality reports for the facilities.

Furthermore, a manual system does not allow full advantage to be taken of the large volume of information that people have compiled. Regrettably, you can see that in many cases a big effort is made to gather the information, and then risk analyses are not applied which would enable environmental monitoring to be adapted to the specific situation of the company through risk analysis management.

4. Could you describe SherpaPharma in just a few words?

It is a holistic solution that facilitates the management of all the steps in the environmental monitoring process, from planning to drawing up reports to ensure compliance with regulations on Data Integrity and recording of information in a GMP environment. As a tool, it is easy to use and it brings a lot of value to different areas of the company (QA, Production, Microbiology QC and Technical Management).

SherpaPharma process

5. Why do say holistic? What is it that makes SherpaPharma such a global environmental monitoring program?

This is clearly stated in the GMPs where it says that environmental monitoring is the responsibility of all the departments involved in the process: Quality Control, Production, Maintenance, Quality Assurance and Technical management, because the information shown in the results is the consequence of the actions / decisions taken by the different departments:

  • Microbiological quality control acts as a “notary public” attesting to the conditions that exist in the company’s different facilities. Its task, without any extra handling, is to take a sample, analyse it under the required conditions, obtain results, interpret these and then transfer them.
  • The production area is responsible for the activities performed in the facilities, with respect to both production itself and compliance with the movement of staff and established goods, and with the processes to clean and disinfect the facilities.
  • The maintenance area may be responsible for ensuring that the calibration of the different elements involved is valid, from elements such as the condition of the HEPA filters, preventative maintenance of the machine to avoid particles, the air samplers for viable and non-viable particle monitoring, etc. In many cases it may also be responsible for the maintenance of water installations, pharmaceutical quality or compressed gases.
  • The quality assurance area is responsible for ensuring that all the activities are carried out and that the actions taken in the facilities are correctly documented. If out of trend results or deviations are observed, this area should take part in the investigations to find the possible root causes of the problem, draw up a plan of corrective and/or preventive actions, and finally evaluate their effectiveness.

6. What advantages does a system of this type offer in the cloud?

The main advantage of having this data in an electronic system is its ease of access for all the departments involved. The fact that the data is in the cloud means its access is controlled and it can be accessed from anywhere. In other words, whenever necessary, access can be gained to the information without the need to be in the facilities.

Another advantage is the security of the data, which is managed in a high availability environment in compliance with ISO 27001, with daily backups in different geographical locations. None of these processes represent a burden for clients’ systems departments.

From the supplier’s perspective, we gain improved management of the versions of the system and we can ensure the compatibility of versions between the applications and the different versions of the software existing in the market as they evolve. This leads to an another important advantage for the client: they do not have to worry about installing new versions or validating these, since we manage this process.

7. Could you tell us a little about the dynamics in data analytics in SherpaPharma?

One of the advantages of having the data in a system like SherpaPharma is the variety of ways in which the existing data can be analysed.

Through the use of filters, specific data it is wished to evaluate can be selected in order to make a customised report. Risk analyses can be conducted with SherpaPharma, filtering by the main parameters in a risk analysis:

  • Staff: (to evaluate specific data about a worker, or the person who has taken a data set, or the person who has read this data, etc.).
  • Facilities: from the specific point, such as the behaviour of a room, an area, a department, a specific facility, etc…
  • Media: it is possible to filter data by medium batch used, and so in the event of problems with a specific batch, the impact on the different results obtained can be evaluated.
  • Instruments: the samples taken can be correlated with one of the different pieces of equipment / instruments used during the process, such as the air sampler, the sampler head, an incubator, etc. In this way, it is possible to evaluate the implications of the use of instruments in a contamination incident.
  • Methods: samples can be selected by type in order to conduct studies by type of sample.

Mobile device and barcode reader

8. What type of company is the ideal candidate for implementation of SherpaPharma into its facilities?

SherpaPharma can be adapted to any type of company. It is currently in use in companies of different types: large pharmaceutical companies, veterinary companies, companies manufacturing sterile healthcare products, low volume parenteral products, etc.

The type of company is not important; what is important is that there is a team that is motivated to implement a system that will lead to improving a key process in the company.

The most complicated elements of implementing SherpaPharma are the generation of internal documentation and the procedures for training the staff involved. This is why we make these stages easier during the process of introducing the system.

9. What procedure is followed to introduce SherpaPharma into the company? What steps are taken?

We have a set procedure for implementation of the system in order to guarantee its success.

We begin by learning about the current process in operation, and when we introduce the system we make it as similar as possible to the current process.

Project monitoring meetings for the implementation of the system are systematised and we ensure that clients are accompanied throughout the process.

10. What is your relationship with the client once SherpaPharma has been introduced into their facilities?

The process does not end once the configuration of the company in the system has been completed and the system is in use.

In some cases, when new functionalities are developed, presentations of the solutions are made in order to learn people’s opinion about them.

Finally, and periodically, when improvements are made to the system and new versions are presented, training sessions are held with the clients to present their new features.

11. Could you provide an example of what you have said by telling us about a successful case?

I would like to highlight the implementation process we completed in parallel in two companies in Germany at the height of the COVID-19 pandemic. It provides a clear example of all the advantages I have mentioned during the interview.

  • Implementation in the Cloud: It wasn’t necessary to travel to Germany to implement the system in their servers. It was possible to configure the company in the system remotely, training sessions could also be conducted remotely, and planned and ongoing monitoring of the entire implementation process could be carried out.
  • Multidisciplinary team for the implementation: They clients were very clear about this process having to be handled by a multidisciplinary team (production, microbiology and quality assurance) to ensure uniform knowledge about the system. The training sessions went ahead and the companies were accompanied in the implementation despite being confined to their respective homes. They were well aware of the implementation stages and the time periods established were met.
  • Adapting the system to client requirements: Specific environmental monitoring standards exist, but their application is different in each company. During the training process, the client pinpointed one or two improvements to the system so that it could be adapted to their specific working needs. An internal evaluation was made by the SherpaPharma team and the process flow was developed subject to agreement with the client. The latest version has integrated these developments, representing an additional improvement for existing clients.

12. What is the future of microbiology in sterile product manufacturing companies?

In my opinion, in the pharmaceutical industry the person responsible for the microbiology department should have a quick and effective tool for analysing the results and trends in environmental monitoring with efficiency; this will assist them in the process of defining the company’s contamination control strategy (CCS), with the aim of reducing the risk of contamination and ensuring the final quality of the products commercialised.

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About the author

Sherpa Team