What is a veterinary cleanroom? Requirements, standards of veterinary cleanroom
Veterinary cleanrooms are a mandatory factor for veterinary pharmaceutical factories. In order for the factory to be licensed to operate production, clean rooms must meet many strict standards and requirements.
So what is a veterinary clean room? What standards do veterinary medicine factories need to meet when building clean rooms? GMP Groups will answer the above questions through the following article.
What is a veterinary cleanroom?
Clean rooms are specially designed workspaces. There, parameters such as urinary concentration, temperature, humidity, pressure, microbial limits,… Controlled and restricted.
Veterinary cleanroom is a cleanroom system applied in the field of veterinary pharmaceutical production.
Requirements, standards of veterinary cleanroom
Applicable standards
In developed countries, the production of veterinary drug products must comply with the same good manufacturing practice (GMP) guidelines for humans e.g. GMP-EU.
In Vietnam, decree 35/2016 detailing a number of articles of the Veterinary Law clearly states: the production of pharmaceutical products or veterinary vaccines must comply with the principles of production of GMP-ASEAN or GMP-WHO pharmaceuticals or GMP-WHO standards equivalent but not lower than GMP-ASEAN.
With concerns for the veterinary industry increasing, the requirements for the quality and safety of medicinal products for veterinary medicines will be increasingly tightened. This means tightening the application of the principles and standards of the GMP guidance system.
Since the GMP standard principle for the production of veterinary and human medicines makes no difference, to control the drug production environment, it is imperative that production facilities use a “cleanroom” system in the construction of factory facilities.
Similar to the human drug product, depending on the nature of the product produced, the veterinary medicine clean room will be divided into various levels of cleanliness to control its environmental factors especially the concentration of urination and microbial limits. In pharmaceutical production, clean levels include 4 types A, B, C, D; It is based on ISO 14644.
Design and construction principles
In order to control environmental factors well, cleanrooms must adhere to the following principles:
Design and layout
Clean rooms must be designed and arranged so that production is carried out in successive areas in a reasonable order corresponding to the order of production activities.
Working area
During the production process, there must be enough area to arrange machinery and materials in a reasonable order. It is necessary to minimize the risk of confusion between products or components of the product. Avoid cross-contamination, minimize the risk of omissions or misalisnment of any production steps, inspections.
Contact surface
The surface of the clean room where direct contact with the open product must be smooth; There are no cracks, no openings. The surface must not be the source of accumulation and feces. They must allow for easy and effective cleaning of disinfection.
Difficult area to clean
Ducts, light troughs, ventilation points and other services must be designed and installed so as to avoid creating difficult-to-clean niches. At the same time, it is required to carry out maintenance and access to these services from outside the production area.
Drainage
The drainage lines must be large enough, designed and equipped to avoid reflux. If possible, avoid open drainage. In case the open exit route is necessary, it is recommended to build a farm for easy cleaning and disinfection.
Ventilation
Cleanrooms must be well ventilated, have air control equipment (including air filtration equipment at sufficient levels to prevent contamination and cross-contamination as well as temperature control, and humidity if necessary) in accordance with the products being processed, in accordance with the operation performed and with the external environment.
GMP Groups – Prestigious veterinary cleanroom design and construction unit
The market currently has many units constructing pharmaceutical cleanrooms, but most units are only capable of providing one of the stages of cleanroom construction, which makes businesses take longer and more time and costs.
GMP Groups Services
GMP is proud to be the construction unit, designing a clean veterinary room package; capable of delivering the most comprehensive and synchronous service. Comprise:
– Consulting veterinary factories meeting GMP standards
– Veterinary cleanroom design consultancy
– Supervision and construction of veterinary clean rooms
– Training, making dossiers of appraisal and re-evaluation of GMP for the factory
GMP Groups – Prestigious veterinary cleanroom design and construction unit
The reason to choose GMP Groups as the construction unit, designing a clean veterinary room
GMP Groups is trusted by investors as a veterinary cleanroom service provider by:
3D design system and VR-360 technology is a technological breakthrough of GMP Groups. This technology allows customers to experience the most vivid factory space and clean room right from the design stage.
– Experienced, enthusiastic, dedicated staff. GMP Groups’ employees are pharmacists and engineers who have been operating for 5-15 years in pharmaceutical companies.
GMP Groups understands the production technology of each dosage form. From there, we will provide our customers with the most effective and suitable design solution.
– We understand the requirements of cleanroom, clean supply, machinery and equipment- people in each stage of production. We can calculate for customers the requirements of area, air treatment system suitable, economical, most efficient.
With the desire to bring a comprehensive service ecosystem related to the pharmaceutical sector, GMP groups will be the perfect choice for any customer’s needs.
For more information on CONSULTING – DESIGN – CONSTRUCTION OF CLEANROOM, please contact:
GMP Groups Joint Stock Company
Head office: Lot LK20.8, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province
Hotline: 0945.255.457 – Website: gmpgroups.com.vn – Email: info@gmpgroups.com.vn