In this Newsletter we have been given the opportunity to present a MEDICAL CANNABIS project, specifically the project of:

MM MEDICAL FLOWERS S.L. located in Lepe (Huelva) but before this, we think it is important to make a brief presentation of the Cannabis team and what we do.  

Three of us are directly linked to this department:

• Roger Janer
• Cristina Parra
• Eudald Bogatell

We have a presentation talk to do with all of you​!
 

Although there are only a few of us, in each phase of our projects we are joined by people from different departments of Valtria in order to execute our work:
 

• Sales, purchasing, production, administration, marketing, logistics, BIM (Building Information Modelling), HR, finance, H&S and at the same time we collaborate very closely with DEVECAN.

PHASES OF A  MEDICINAL CANNABIS PROJECT 

• CONCEPTUAL PHASE
  After initial contacts with the client, the client sends us an order for the development of the conceptual project. This is where Eudald Bogatell in collaboration with Cristina Parra receive the client's needs, ideas, intentions and concerns and begin to design the complete production process based on the information received in collaboration with DEVECAN's partners.
  
  The importance of this phase is to advise and accompany the client, until a concept and the necessary information can be presented so that the client can get a real idea of the overall scope of the project. At the same time, together with DEVECAN, the first documentation is being prepared for submission to the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS).
   
• COMMERCIAL PHASE
  In this phase, once the client has decided to go ahead with the project, and they ask us for an economic offer for the installations. Here it is Cristina Parra's job to set down in a state of measurements and a basic design, the conceptual project presented and to put a price tag on it. Throughout this phase, there is close cooperation with the commercial department.
   
• PRODUCTION PHASE
  From the basic project Cristina Parra and the site technician develop the executive project and the construction phase begins. The special feature is that the design of the installation is by Valtria. As on all construction sites, collaboration with BIM, procurement, logistics, administration and H&S is crucial for the correct development of the project.

Having made this brief outline of the department, ¡we will now describe the project!

MM MEDICAL FLOWERS
Location: C/Cañada del Pilar num 9, 21440 Lepe (Huelva)

The CLIENT´S GOAL is to obtain:

• High-quality dried Cannabis flowers to access the market for medicinal use. 

The project in question includes a first phase of 4 flowering fields of 576 m² each, with future expansions envisaged up to 12 fields of 6,912 m² each.
The building and common services of this first phase include the possibility of integrating future extensions, which can be adapted to the product and process needs of MM Medical Flowers.

From each field we expect to obtain 4 harvests per year and from each harvest we will obtain approximately a 700 kg batch of green plant which when dried will be reduced to 156 kg of dried flower.

DESIGN CONSIDERATIONS

• Layout of the GMP warehouse
  The total area of the GMP warehouse is 423 m², of which 270 m² are ISO8 classified rooms. [...]

• HVAC system design
  Hot and cold water production for HVAC is provided by a 4T heat pump with an output of 215 kW for cooling and 259 kW for heating [...]
• Installation specifics
  When working with a product that is a living being, we must be mindful throughout the process to prevent it from spoiling or becoming contaminated by fungi or bacteria. [...]

THE SCOPE OF THE PROJECT
In this project, the following works have been carried out:

• Installation of panels
• PVC and resin flooring
• HVAC installation
• Control Systems installation
• Installation of electricity and lighting.
• Plumbing in rooms.

FIRST COMPLETED CHALLENGE OF THE CANNABIS TEAM!

This was the first medical cannabis project for the department, not Valtria's first. It has been a challenge to coordinate the team and with the client, reaching a very high level of responsibility, advice and trust with the client and all this would not have been possible without the Valtria team, Eudald, Cristina, Marcelo, Enrique, Roman and Eugenio and as always with the collaboration of all the Valtria departments that make the works easier.

> DOWNLOAD THE FULL DOCUMENT

Once again, FARMAFORUM 💊

The place where we gather lovers of innovation in:
Pharmaceutical Industry, Biopharmaceutical and Laboratory Technology.
We have organized ourselves so as not to miss any of its specialized areas such as Health&Research Forum, Cosmeticsforum, Biotechforum, Nutraforum and Cannabisforum.
 
🗓️ We sponsored table 4, in which we discussed:
"The regulatory framework of restriction enzymes, plasmids, viral vectors and radiolabeled CART-T cells." 💬
 
🗓️ We also discussed "The regulations applicable to the cultivation, manufacture and distribution of cannabis-based products for medicinal purposes in Spain and Europe" with our Business Development Director, Enrique Corral.
 

😍 We have said goodbye with very good impressions.
📷 We leave you some photos of these days, pre-fair and fair!
✨ See you next year!

👇👇 DAY BEFORE THE EVENT 👇👇

📣  Next stop, BIOSPAIN 

We did not want to miss the opportunity to be present at BIOSPAIN!
The international biotechnology event in Southern Europe, where during three days, we have met with different innovative entities working in:
 

• Health solutions
• Sustainable agri-food
• Climate change

👇👇  DAY BEFORE THE EVENT  👇👇
 

📷   Here is a photo of the event!

This month we don't stop, ILMAC  ✨

Our team from the Valtria Switzerland delegation supported us at ILMAC!
🙌 For three days professionals from the chemical and life sciences industry have gathered in Switzerland.
 
✅ 400 empresas expositoras
✅ 10.000 visitantes profesionales 
✅ 100 lectures and presentations  

🗓️  Dureid Qazzazie discussed about: "Facing challenges of today’s advanced therapy environment with the aid of closed isolator technology" 💬
 

📷  Here is a photo of the event!
 

Finally, MEDICAL CANNABIS EUROPE

One more year,
WE ARE GOLD SPONSORS!
The Valtria Portugal delegation supported us at the third European Conference on Medicinal Cannabis, organized by the ANF (Associação Nacional das Farmácias).

In this event the regulations applicable to the cultivation, manufacture and distribution of cannabis-based products for medicinal purposes in Portugal and Europe were discussed and clarified.

HERE YOU HAVE THE ARTICLE PUBLISHED IN FARMAESPAÑA INDUSTRIAL MAGAZINE!

BY OUR COLLEAGUES:

• EUDALD BOGATELL
• IN COLLABORATION WITH: FREDERIC PASCUAL Y LIDIA CAMPILLO

PARTICULARITIES OF THE APPLICATION OF GMP IN THE DESIGN OF MEDICAL CANNABIS FACILITIES

Good Manufacturing Practices (GMPs)  are not standards and guidelines, as ISO can be, but they are European Directives (2003/94/CE), which were transposed into Spanish law by Royal Decree 2183/2004.

In introduction and conclusion, which are mandatory.

"The large number of manufacturing processes for pharmaceuticals has led to the creation of these standards, so that, with the exception of novel cases, the pathways end up being quite clear".

Their "directive" aspect leaves a certain level of interpretation, which is reduced day by day by the outcome of inspections, official deviations, and supported by literature. In the US, the cGMP (c=current) help to reduce this margin of interpretation.

By "law" we are obliged to ensure the production of "safe, quality and efficient" products. The different regulations surrounding GMPs offer guidelines to reduce this margin of interpretation. 

This allows us to implement these good practices in the design and operation of the facilities. The objective remains the same: to ensure a safe, efficient, reliable and stable drug production result within the set time frame [...].

It is important to remember that a regulation is not mandatory until it is dictated by a decree of law.
It should then be noted that the GMPs mention the ICH and ISO 14644.

Cannabis is a special case within standard medicine manufacturing practices [...]

Application of GMP regulations

• Dried flower of Cannabis "direct use" as a medicinal product
• GMP implementation
• Batch definition
• Flower for medicinal Cannabis extracts

> DOWNLOAD THE FULL DOCUMENT

HERE YOU HAVE THE ARTICLE PUBLISHED IN FARMAESPAÑA INDUSTRIAL MAGAZINE!

BY OUR COLLEAGUES: 

• EUDALD BOGATELL
• IN COLLABORATION WITH: LIDIA CAMPILLO Y GONZALO AGUILAR

In this article we are going to share our experience as a company that installs clean rooms, commissioning, maintenance and qualification services on the importance of integrating the maintenance department in the different phases of the construction of an installation (from design to its entire useful life).

"The pharma sector's huge investments in R&D (in product and process), without good maintenance of the facilities, can cause them not to have their amortization in the foreseen term".

Detailed design phase of new facilities

• The maintenance department must have and deliver from the beginning its URS(User Requirement Specifications) on all types of installations, specifying materials, standardisation of spare parts, brands and finishes to the installer who is executing this phase. 
• Validate the design of the elements.
• Collaborate in the revision of the detailed, executive project, supervising accesses, sectorisations, records for inspections, necessary to facilitate subsequent maintenance tasks.
   

Completion of new works or modifications to existing installations 

• Ensure that the "As Built" documentation is exhaustive.
• We must also ensure that the maintenance plan and procedures are delivered and incorporated into the CMMS system itself.
• When the subcontractors complete their installations, the different finishes, the identification of circuits, wiring and regulation elements will be supervised.
• After completion of new construction or modifications to existing installations, training of personnel is initiated. This training must be appropriate in content and adapted to the professional profile of the staff to be trained. It shall include all installations.
   

Phase prior to the planned intervention

Intervention

Post - Intervention

Conclusions

> DOWNLOAD THE FULL DOCUMENT

WHY DID YOU DECIDE TO JOIN VALTRIA?
It was time for me to look for new challenges and by chance I found job advert from Valtria. I did my research and decided to apply. Job description was spot on, and the company looked like a good match!

WHAT DO YOU LIKE ABOUT VALTRIA?
I enjoy the challenges but what I like the most is the support from the team and this "we can do it together" attitude.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
I have an older house which I like to re-design and renovate.

A WORD THAT DEFINES YOU:
Calm, adaptable, flexible.

WHY DID YOU DECIDE TO JOIN VALTRIA?
Although leaving my previous company after more than 13 years and moving to Spain was not an easy decision to make, I am very glad I did! 

WHAT DO YOU LIKE ABOUT VALTRIA?
I really enjoy the projects we work on every day in the Major Projects Unit, I love my co-workers, and the office atmosphere in general. Valtria has made me feel at home.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
As for my hobbies, apart from travelling and meeting new people and places, I like to spend my time reading books, visiting museums and theatres, getting lost in the mountains, or doing DIY. 

A WORD THAT DEFINES YOU:
The word that, I think, defines me the most is "determined". I am the kind of person who, if I once decide to do something, will do it no matter what the effort. 

WHY DID YOU DECIDE TO JOIN VALTRIA?
I have always been in engineering and I wanted to experience the other point of view of the projects but without leaving the cleanroom sector because I am passionate about it and Valtria is a reference company. The new role I have here is different from what I was used to and this, for me, is a challenge that motivates me even more.

WHAT DO YOU LIKE ABOUT VALTRIA?
From the first minute you feel at home. They provide you with everything you need to carry out your work. You are listened to, taken into account and your knowledge and contributions to the company are highly valued. I also value very much the work that is done on the human side, because we are people and this must be kept in mind.  

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
My whole life has been hoquei skates, but since I hung up my skates I've been doing duathlons. I also love to travel with my backpack to the most remote places on the planet or escape to the West End for a marathon of the best musicals of the moment, I love them! Of the little time I have left over, I like to read and sail.

A WORD THAT DEFINES YOU: Persistent

WHY DID YOU DECIDE TO JOIN VALTRIA?
Because I consider it a company with clear objectives, a place where I have the opportunity to develop professionally without my work taking over my personal life.

WHAT DO YOU LIKE ABOUT VALTRIA?
Its transparency, it has collaborators with both professional and human quality; and in the short time I have been there, I have found congruence between what they say and what they do. I met Valtria in 2018, at a Pharmaceutical Symposium to which I was invited. I know that, although it had a focus on marketing and doing business relations, I liked that they shared knowledge and I love their corporate image.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
At least once a week I get away from the city and go to places where I can live with nature, where I can disconnect for a while. I also go to places where I can listen to live music, be it concerts, bars, festivals or on the street, I love music, and listening to it live frees me up and recharges my energy.

A WORD THAT DEFINES YOU: Natural

WHY DID YOU DECIDE TO JOIN VALTRIA?
It was a combination of several circumstances. I was living in Colombia, but I was looking to return to Spain. Additionally, I was already familiar with the company, and I was very attracted to the idea of trying it here.

WHAT DO YOU LIKE ABOUT VALTRIA?
Above all, having moved from one sector to another, even though they are closely related (HVAC comfort installations), I have seen that I have a lot of room for improvement and I love that. I would not forget to mention the excellent working atmosphere.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
On the sports side, I enjoy basketball, surfing, and working out at the gym. I love to debate and take a stand against "popular" opinion. I enjoy being with people, but I also enjoy my solitude.

A WORD THAT DEFINES YOU:
My friends say "competitive", I would say "peculiar".

WHY DID YOU DECIDE TO JOIN VALTRIA?
Valtria offered me a position where I could develop my skills and experience gained so far. In addition to the challenge of joining a company like this, located in a sector that is new to me.

WHAT DO YOU LIKE ABOUT VALTRIA?
I really liked what I had heard so far about their company culture and I knew I wanted to be part of a company with as many possibilities as Valtria.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
I currently play sports such as paddle tennis and running, although since becoming a mother I have less time for it. Until not so long ago, I even practised martial arts and competed at national level.

A WORD THAT DEFINES YOU:
I consider myself to be an active person, both inside and outside work.

WHY DID YOU DECIDE TO JOIN VALTRIA?
I have always worked in clean rooms and controlled environments, from small to large companies and wanted to get back to helping customers in these types of projects, from the design phase through to validation so when I heard about Valtria's extensive experience, I was interested to learn more, my decision was clear.

WHAT DO YOU LIKE ABOUT VALTRIA?
First of all, our team spirit and to know that when I have questions in any area we can find answer to them together. Also, I like, that by saying that we share our internal international resources really means that. Furthermore, that our founders are experienced cleanroom professionals form different fields sharing my personal point of view and are in that aspect able to support in all day-to-day and engineering initiatives.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
I love sailing with family and I´m passionate road biker.

A WORD THAT DEFINES YOU: Enthusiastic

WHY DID YOU DECIDE TO JOIN VALTRIA?
I am excited about the opportunity to work with a high-level team that is a leader in a growing industry and is implementing the latest in BIM technology. Also to be able to collaborate in projects that have a real impact on health and science.

WHAT DO YOU LIKE ABOUT VALTRIA?
What attracted me most to Valtria was its leadership and recognition in the market, the possibility of growth and the opportunity to lead international projects. I deeply value the working environment I perceive in the company and being able to collaborate with professionals from different backgrounds and experiences.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
In my free time I enjoy clearing my mind by painting watercolours and doing physical activity. I also do courses, learn languages and enjoy spending time with loved ones!

A WORD THAT DEFINES YOU:
Creative

WHY DID YOU DECIDE TO JOIN VALTRIA?
I was interested in the seriousness with which the company projects itself, the medium and long term objectives and goals, the challenges in the technical areas and I felt that from my experience and profile I could provide a relevant added value in the different activities that we develop.

WHAT DO YOU LIKE ABOUT VALTRIA?
In addition to the above and equally important, the human team of its members has made me feel welcome in an excellent environment, generating work synergy and a very cohesive team.

AND OUTSIDE VALTRIA, WHAT ACTIVITIES DO YOU ENJOY IN YOUR FREE TIME?
Sports (Crossfit), reading, recreational activities with my daughters and going out to a restaurant with my wife and friends.

A WORD THAT DEFINES YOU:
Dynamic