Publication of the book “Karriereweg in der Pharmabranche” by Dirk Geest

“Interview with Dirk Leutz, Managing Director, Pitzek GMP Consulting GmbH”

The new Annex 1 and the effects during sterile product manufacture

About visual inspection

Hobby & responsibility
A clean community

“We keep our community clean”

– Streets, paths, green areas – all full of litter. Everyone complains, but nobody does anything about it.

Interview with our colleague Benjamin Peschke, Sales Manager at Pitzek GMP Consulting: “We take personal responsibility for keeping our community clean!”

Benjamin, what gave you the idea of starting a private initiative to clean up litter in your community? Isn’t that excessive? Don’t you pay property taxes for that?
We always notice streets, paths, and green areas in our community that are full of litter. Everyone complains, but nobody does anything about it. That bothered me. I am for actions, not words, my family and I decided to get to work, collect the litter, and get rid of it. People litter the community, and if the municipality can’t keep up, it doesn’t matter how much property tax I pay.

You’re setting a great example. How did you get started?
The example is especially important for the kids, who we want to sensitize for later. We want them to learn that you have to get to work yourself if you want to change things. Litter is especially bad for animals, and our kids love animals.
So they got their own trash grabbers, which happened to be free gift with a children’s magazine. From the first, they had a blast making the rounds and picking up litter. They may have gotten a little bit tired after a while. 😉

How did people find out about it, and how did the municipality react?
We contacted the municipality. They were enthusiastic and gave us a sponsorship. They provide grabbers and trash bags, pick up the trash at a specific location, and haul it off. We also participate in a municipality “Take Out the Trash” day. We contribute to keeping our community clean and feel good about ourselves because we have helped the environment.

Were you able to recruit more people from the community to help you with your project?
My wife is working with the kindergarten to organize a private “Take Out the Trash” day. She is active in the parents’ group there. It is especially educational for the kids there and gives them a new way of looking at the world, so many parents were enthusiastic as well.

What do you do with the larger pieces of trash like tires and mattresses? You see things like that once in a while in our communities. You need more than a grabber for something like that.
Our solution is a great trash app. We can take a picture and send it to the municipality, and they come and pick it up. It works really well!

So what is your overall impression?
One thing is that our daily route to the kindergarten is clean. Another is that if you want something done, you sometimes have to do it yourself!

Pitzek’s conclusion:
There are parallels to the job you do for us. We know you to be a man of action. Your vigorous activity in this project reflects the personality we have seen on display in your work as sales manager at Pitzek GMP Consulting. You give it everything you’ve got, take responsibility, keep your cool, and are always in a good mood! This has been a great benefit to the company. We are very thankful.

Pitzek GMP Consulting joins customers, partners, and employees in looking back on ten years of corporate success

Among the highlights were the keynote address by former Bundesliga referee Knut Kircher; a very enjoyable, relaxed speech on “Continuous manufacturing” by Steven Miller, who is part of the executive management of Hecht Technologie GmbH; and refreshing cocktails, great food, and benefit goal wall shooting for the LICHTBLICK meeting place in preparation for the World Cup! The guests were also enthusiastic about the unusual location.

Unlike most corporate ten-year anniversary celebrations, this one involved customers, partners, employees, and a big party. And there was plenty to celebrate.Exactly ten years ago, Dr. Denise Pitzek und Thomas Pitzek opened the first office in their private house in the Palatinate. The headquarters has been at Neustadt an der Weinstraße for seven years. During this period, the location has seen great successes. The office in the Wallgasse in Neustadt is one of four locations and ensures that employees and companies from around the region can get together. You have to be a little bit crazy to work at Pitzek, but it also helps, as the company emphasises in its image spots and elsewhere.“Not taking ourselves too seriously and still being down-to-earth, responsible, and professional, meeting clients on an equal footing – that’s what we’re about.  There are very few people who do everything right, but we have done at least most things right – otherwise we wouldn’t be where we are,” , ssays Thomas Pitzek, founder of Pitzek GMP Consulting GmbH.

Values and corporate culture were central issues at the event. In their opening remarks, the founder and the managing director, Thomas Pitzek and Dirk Leutz, emphasised the company’s special spirit. Pitzek GMP Consulting is a passionate company in which the corporate culture, respect for each individual’s personality, and long-term commitments and team-oriented cooperation are greatly valued. Another advantage that Pitzek GMP Consulting GmbH enjoys and that distinguishes it from the competition in the area of teamwork, customer orientation, and reliability is the employee philosophy:WE ARE WHAT WE PRACTICE!

Since its founding in 2012, Pitzek GMP Consulting GmbH has successfully implemented hundreds of challenging projects, initially as a family-run company. It now employs more than 40 specialists in pharmaceuticals, food, and biotechnology. Under#projectsaroundyouLeutz looks out for the team of more than 40 consultants and tracks needs and requests from employees, applicants, and life science companies  „W”We are made up of very diverse regional teams and practice our identity in our own way, and we are proud of that. We are currently advertising more positions and are really looking for help constantly thanks to our continuous growth – but that help must fit perfectly with our team,”says Managing Director Dirk Leutz.

Marketing, sales, and project teams all pull together and cooperate in further promoting brand awareness.„“Our in-house marketing, which we introduced almost seven years ago, has established Pitzek GMP Consulting as a special brand for high-quality consulting and services provision in the pharmaceuticals, biotech, and food industries,” says founder Thomas Pitzek. 2022 has been heavily influenced by the new “GENIAL, LOKAL” campaign, which breathes fresh air into our image.

About Pitzek GMP Consulting GmbH
Pitzek GMP Consulting offers holistic consulting for regionally, nationally, and globally active pharmaceuticals, biotech, and food companies – and has been doing that for ten years. The recipe for the company’s success is solidly based industry, process, and strategy knowledge; far-reaching familiarity with national and international markets; and a strong focus on the regions around the company’s locations. From new construction to comprehensive restructuring to minor adjustments, Pitzek’s goal is to develop GMP-compliant concepts, effectively optimise processes, and reduce costs, all while carefully adhering to requirements and regulations.

Consulting competence is right around the corner. As it has been for ten years..

Pitzek GMP Consulting, your pharmaceuticals, biotech, and food technology expert in the Rhine-Main-Neckar area and Berlin, Germany, and Vienna, Austria.

NNew career opportunities and consulting competence acquired by changing the location of Pitzek GMP Consulting GmbH’s GMP experts..

The Austrian subsidiary of Pitzek GMP Consulting is moving from Salzburg to Vienna.

There are a variety of factors that affect a company’s growth and thriving. The company is changing its location to be closer to the pharmaceuticals industry and thus to the customers. Vienna has established itself as the commercial hub of the Austrian pharmaceuticals industry. A strong location requires bold ideas – the kind the Pitzek GMP Consulting can provide.

All customers, partners, and advertisers should therefore note a new Pitzek GMP Consulting GmbH (Austrian subsidiary) for both appointments and correspondence.

In future, the office can be reached atPitzek GMP Consulting GmbH
Subsidiary Austria
Weihburggasse 21/13
1010 Wien

Mobil
Festnetz  +43 (0)143 800 58 

New outlook with a new managing director
Since August 2021, Dirk Leutz has been the new managing director and thus the man responsible for advancing Pitzek GMP Consulting’s business development, as he has been doing with great dedication. Says Leutz, “Previously, I was Technical Manager/Division Manager Engineering for Pitzek. So I am at home in the organisation. I am looking forward to my new challenge and to being able to provide new ideas.” Thomas Pitzek, founder of Pitzek Consulting, adds, “We are convinced that Mr Leutz, with his expertise and level-headedness, is a find for our company and our customers.” In the pharmaceuticals circles in Vienna, we intend to remain very close to our customers. This ensures efficiency with reduced costs, quick reaction times, and short travel distances.”

Pitzek GMP Consulting has been offering purposeful project management in the GMP area for pharmaceuticals, biotech, and food technology companies for ten years. Its services are customised, fast, uncomplicated, effective, and customer-oriented.

From its Location Neustadt/Weinstraße Pitzek can quickly reach customer locations in the Palatinate and the Rhein-Main-Neckar area. Pitzek offers the same services in the   from the Berlin branch , supporting customers with all its expertise. 

From new construction to comprehensive restructuring to minor adjustments, Pitzek’s goal is to develop GMP-compliant concepts, effectively optimise processes, and reduce costs, all while carefully adhering to requirements and regulations.

“Our customers in the Rhine-Neckar area and in the Northeast of Germany enjoy local proximity to our Neustadt/Weinstraße and Berlin branches. This ensures reduced costs, quick reaction times, and short travel distances. In other words, we are looking for proximity to the customer in a literal sense,” says Leutz.

“CLEAN REALITY” – doing it right once is enough!

On 3/3 at 3:00 PM, we started the fascinating second part of the IWT Cleaning Excellence by Tecniplast and Dr Weigert – Systematic hygiene webinar, addressing the main issue of “Cleaning in the GMP-governed environment”.

We are very pleased that the second part of the webinar was also a complete success. We started off in 2022 with almost 100 participants. The moderators addressed many interesting questions and hopefully were able to answer them satisfactorily.

We would like to express heartfelt thanks to all webinar participants and are pleased to have been able to offer 60 valuable minutes covering everything from implementation to validation.

You couldn’t find the time or got stuck in another meeting? Then we invite you retroactively to the second part of our joint webinar with IWT and Dr Weigert.

Enjoy 60 stimulating minutes on topics ranging from implementation to validation:

CLEANROOM TECHNOLOGY AND CONTAINMENT

Annex I and what to watch out for in material and/or personnel locks

The biggest contamination hazard in cleanrooms is from personnel. Transferring equipment and material into the cleanroom also involves critical contamination hazards.

All activities that could affect cleanroom classification status should be given careful attention. Suitable checks must be made regularly. Such checks include particulate and microbial monitoring. Particulate monitoring can be performed by a continuous measurement system or as spot checks at regular intervals.

Equipment and material transfer and personnel access to classified areas should be through material or personnel locks and in one direction only. Personnel must undergo washing and changing processes before entering classified areas.During the lock process, material is made cleanroom-friendly by unpacking or disinfection. For transfers to an aseptic or sterile area, a sterilisation step should be performed if possible.

If no sterilisation is possible, a suitable measure should be validated and performed so that contamination risk is minimised. Suitable measures include effective transfer disinfection, quick transfer systems for isolators, or, for gaseous or liquid materials, an anti-bacterial filter.

An innovation for personnel and material locks that has been added to Annex 1 is spatial separation between personnel and material locks. If such separation is not possible, at least a temporal separation should be considered.

We recommend using separate locks from at least Cleanroom Class B if our risk analysis indicates a heightened contamination hazard. This means separate locks for incoming and outgoing materials and separate locks for incoming and outgoing personnel.

Would you like consulting on material and personnel locks in cleanrooms? Don’t hesitate to contact us at:

juliane.schulz@pitzek-consulting.de
Mobil: +49 (0) 160 178 38 20

Hobby and passion
Essential oils

“Essential Oils”

and their connection to GMP – complete purity

Synthetic or harvested from natural sources by means of steam distillation, extraction, or squeezing plants or parts of plants.

Interview with our colleague from Vienna, Sabine Hell-Kuncinger:

So, Sabine: Why essential oils?
They work at all levels (physical, mental, psychological), and a scent molecule reaches the limbic system in three seconds.

Essential oils have been used for thousands of years, and they can be found in every herb, every plant, in blossoms, and so on. They are PURE NATURE – which is why these molecules manage to penetrate our cell membranes and reach directly into the cell and its nucleus.

Essential oils can have stimulating effect and work as pick-me-ups (these include orange, lemon, lime, and grapefruit – that is, all citrus oils) – and in this form are perfect for our daily challenges at work; they can calm you and your spirit (most people are familiar with lavender); they can cool you off and stop your headache (peppermint, spearmint); they can stop or at least slow inflammatory processes (frankincense), relieve colds (hot tea with lemon, ginger, and a special “thieves” oil blend), and much more.

So, Sabine, to summarise: These oils are extremely flexible. About as flexible as we have to be in our job, right? Do you pay attention to how the oils are produced and were they come from?  Yes, I was really impressed by one company because the quality of its essential oils was absolutely pure. Starting with planting, all the production steps through to packing were carefully monitored and documented precisely.That is GMP style.

You can even visit the farms where individual plants are raised and help harvest them.

How varied are these oils? Are there special characteristics?
Each essential oil, even if it comes from the same area, smells different. Depending on the weather conditions, the essential oils have a slightly different composition each year. A single drop of rose essential oil requires about 30 petals. That comes to between three and a half and five tons for a litre of essential oil.

By the way, rose is considered a mood enhancer and is very helpful for depression.

Can I use these oils in my daily routine?
Of course essential oils can also be used for cooking. If you are baking, you can use vanilla, lemon, and so on. If you are cooking, you can use basil, sage, dill, and so on. Either way, essential oils can provide the extra kick you need.

What is the best way to use essential oils?
You can apply them to your skin, evaporate them with a diffuser, and take some of them orally.

Summary:
The thing that essential oils have in common with Pitzek GMP Consulting services is that a selection of both can be used in a targeted manner to address specific issues!