Dehumidifiers for the Pharmaceutical Industry
A controlled environment is necessary for the preparation of pharmaceutical products, as they are submitted to countless processes and are highly sensitive to temperature variations, as well as very susceptible to humidity.
It is worth mentioning that the slightest oscillation in the humidity percentage may compromise a whole batch of medicine.
HUMIDITY DAMAGES
MANUFACTURING
Formula (it can be liquid, cream, or powder):
Water vapor may make it difficult to grind or mix the product. Humidity below 20%.*
Compression:
End product may be damaged and present breakages, chips, and cracks. Humidity below 20%.*
Capsule Compaction:
It may cause flaws in the formation process.
Coating:
Coating may be rough, translucid, and uneven if refrigeration and drying are incorrect.
Blister packaging/Bottling (Manufacturing stage, when the product is packed):
The capsule may break and crack, and packages may not be built correctly.
PRODUCT
Effervescents:
It may change finishing and efficacy.
Penicillin:
Humidity shall be controlled between +-0,25 and +-3% during incubation.
Injectables/Ampoules: Change in color, leakage, and formation of crystals.
Cream or ointment: Decrease in volume, change in consistency, or presence of a liquid when the tube is tightened.
Gelatin capsule Changes in consistency or appearance (softening or hardening).
Capsules
STORAGE
It shall be controlled to avoid changing the stability of the medicine.
CONTROL IN PROCESS
If humidity is not controlled, it can cause contamination.
PACKAGING
There is a possibility of deterioration of hygroscopic materials.
When the level of absorption of water is extremely high, the material starts to dissolve due to the water it has absorbed.
Humidity control is mandatory to ensure products will consistently maintain high quality.
*The ideal temperature for each stage of the process may vary according to the requirements established for each specific medicine.
SUCCESS CASE – IMCD
IMCD, a Thermomatic client, leads the segment of distribution of chemical products in Brazil. It comprises many segments, such as pharmacy and cosmetics.
Guilherme Marsi, in charge of the quality assurance of raw material, attests that the dehumidifier is essential for controlling humidity.
IMCD has the certifications required by the market, such as ISO 9001, and our products also help reaching the Good Manufacturing Practices. Check the video!
LEARN HOW THERMOMATIC CONTROLS HUMIDITY.
EFFICIENCY IN THE MOST IMPORTANT FIELDS
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Technology
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Service
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Solution
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Innovation
With more than 30 years in the market, Thermomatic is a pioneering company in manufacturing and selling air dehumidifiers. Clients are our raison d’être. That is why we praise full satisfaction of the client and always offer efficient solutions with Desidrat Line dehumidifiers, as they:
- Control humidity, and maintains the required percentage pursuant to the Good Practices Manual or ANVISA.
- Prevent alterations to the formula of the medicines.
- Eliminate fungi, mold, and bacteria in storage places.
HUMIDITY CONTROL
Excessive humidity is one of the environmental factors that accelerate chemical and biological reactions. The Pharmaceutical Industry deals with people’s health and several legal requirements, such as ANVISA’s Collegiate Board of Directors’ Resolution (RDC) (No. 17, April 16, 2010) and the quality guide for air treatment and environmental monitoring activity systems, published in March 2013, shall be complied with for quality management.
Humidity may influence medicine manufacturing, so it is necessary to control the processing to prevent cross contamination and, consequently, ensure quality of the end product.
See below some examples of the necessary controls:
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LESS THAN 50%
manufacturing of injectables, test areas
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LESS THAN 35%
manufacturing of ampoules’ powder
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EQUAL TO
OR LESS THAN25%Powder mixes, compound pills, and manufacturing of gelatin capsules
The ideal humidity and temperature for each stage of the process may vary according to the requirements established for each specific medicine.
MAIN CLIENTS OF PHARMACEUTICAL INDUSTRIES
TESTIMONY – BLISFARMA OFFICER
“The air dehumidifier is the ideal solution to control humidity in spaces where medicine is processed. Humidity is an essential factor in the Pharmaceutical Industry, especially with hygroscopic materials. If humidity is not controlled correctly in the manufacturing, packaging, and storage process, for example, the product may lose quality, which goes against ANVISA’s resolution.”
Says Luciana Felisberto, Industrial Officer of BlisFarma. The company offers customized solutions to pharmaceutical services and was awarded for 2 consecutive years (2014-2015), as one of the best suppliers and service providers to the Pharmaceutical Industry, with Sindusfarma Quality Award. Nowadays, BlisFarma is considered a reference in the business, as its operation is customized and dynamic within the pharmaceutical market.
TESTIMONY – VITAMEDIC’S ENGINEERING
As we are in the Midwest region of the country, humidity was very high in Vitamedic. Thermomatic’s dehumidifier managed to reach the desired operating humidity, which ranges from 40% to 50%.
Plus 1000 perfectly met expectations, the equipment operates in the compression room, during the manufacturing process, and its tray stores humidity and throws water directly into the strainer.
I recommend Thermomatic products because they control humidity and the amount invested is low if you consider the benefits we have.
José Gomes – Vitamedic’s Project Engineer
Depoimento – Diretora da Blisfarma
“O desumidificador de ar é a solução ideal para manter o controle da umidade em ambientes de processamento de medicamentos. A umidade é um fator muito crítico na Indústria Farmacêutica, principalmente com os materiais higroscópicos. Se não houver o controle correto no processo de produção, embalagem e armazenagem, por exemplo, os produtos podem perder a qualidade, contrariando a resolução da ANVISA.”
Afirma Luciana Felisberto, Diretora Industrial da BlisFarma. A empresa oferece soluções personalizadas em serviços farmacêuticos e foi premiada por 2 anos consecutivos (2014-2015), um dos melhores fornecedores e prestadores de serviço da Indústria Farmacêutica, do Prêmio Sindusfarma de Qualidade. Atualmente a BlisFarma é considerada uma referência no ramo, pois atua de maneira personalizada e dinâmica no mercado farmacêutico.
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PRODUCTS Thermomatic
Equipment that feature top-of-the-line power and performance for controlling air humidity.
Os Desumidificadores da Linha Desidrat são desenvolvidos dentro da mais alta tecnologia e tem contribuído para a melhor qualidade de medicamentos, suplementos e outros produtos do setor, ajudando nas Boas Práticas de Fabricação e também na obtenção da ISO 9001 (Normas de Qualidade).
Agende sua visita técnica gratuita para indicarmos o produto ideal para a solução da sua adversidade.
