СATALOGUE / EQUIPMENT WITH REVIEWS / PHARMA / OINTMENT PRODUCTION / ANTIBACTERIAL OINTMENT / Basic requirements of gmp soft dosage forms

Basic requirements of gmp soft dosage forms

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СATALOGUE / EQUIPMENT WITH REVIEWS / PHARMA / OINTMENT PRODUCTION / ANTIBACTERIAL OINTMENT / Basic requirements of gmp soft dosage forms

Basic requirements of gmp soft dosage forms

In the manufacture of ointments, creams and other soft dosage forms, there is a particularly high risk of microbial and other contamination. Consequently, special measures are required to prevent any contamination. Soft dosage forms have specific rheological properties and are in most cases heterogeneous dispersed systems. Therefore, in order to avoid product heterogeneity due to uneven distribution of components, formation of gas emulsions and destabilization of disperse systems, special attention should be paid to the correct conduct of the technological process, the equipment used and the temperature conditions of product storage.
Requirements to production premises and equipment. The environment of the premises, taking into account all measures to protect production, should present the lowest possible risk of contamination of materials and products.

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Information updated : 11 / 12 / 2025
In stock
Manufacturer : 1 year for Basic requirements of gmp soft dosage forms

Model: Soft dosage forms

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Equipment on lease with an advance payment of 10%. Convenient payment schedule. No limit. Approval for three documents: passport, lease agreement and extract. We cooperate with leasing companies.

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Materials (cardboard, wood chips, etc.) from which fibers or other contaminants may be separated must not be located in areas where products or clean containers are not protected from the environment. During packaging, it must be ensured that the homogeneity of mixtures, suspensions, etc. is maintained. Mixing and filling processes must be validated. To ensure that the homogeneity of the product is maintained, special care must be taken at the beginning and 6 end of the filling process, as well as after interruptions. If bulk products are not immediately packed and finished products are not immediately packaged, the maximum storage times and conditions for these products must be established and strictly observed.

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Articles — A genre of journalism in which the author sets the task of analyzing social situations, processes, phenomena, primarily from the point of view of the regularities underlying them.

Technical specifications

Closed systems are recommended for the manufacture and transportation of products to protect them from contamination. Production areas where products or open containers are not protected from the environment should generally be effectively ventilated with filtered air. Tanks, containers, piping and pumps should be designed and installed so that they can be easily cleaned and sanitized if necessary. In particular, equipment should be designed to minimize “dead” areas or areas where product residues could accumulate, creating a breeding ground for microorganisms. Where possible, the use of glass equipment should be avoided. Parts of the equipment that come into contact with the product should generally be made of high quality stainless steel.

Additional information

Process requirements. The quality of the water used should be established and monitored with respect to chemical and microbiological purity. Care should be taken when maintaining water supply systems to prevent the risk of microbial growth. Any chemical sanitation of water systems should be followed by flushing according to a validated methodology that ensures effective disinfectant removal. The quality of substances received in angro containers should be checked before they are placed in storage tanks. When materials are transported via pipelines, it must be ensured that they are delivered strictly to their destination.

Order status tracking

Roman Tsibulsky +79853643808 now online

Aubrey
Good day, I want tomorrow until 13:30 to get FF-02 tablet and capsule filling machine in Madrid? 30/12/2025 17:28

Roman Tsibulsky
Good afternoon, Aubrey! We have contacted the transportation company, your shipment is arriving in Madrid without delay. Please wait for a call from a representative of Business Lines. 30/12/2025 17:28

Jackson
Mixer with paddle for powders CX-100 what is the exact packing size ? 30/12/2025 17:38

Roman Tsibulsky
Jackson, Hello! Packing dimensions 1200x640x1000 mm, packing weight 250 kg. Please let me know when you receive the shipment. 30/12/2025 17:38

Aurora
Roman hello, what about the automatic filling and sealing machine for sterile ampoules ABF-4D-1, invoice #101. 30/12/2025 17:48

Roman Tsibulsky
Good afternoon, Aurora! We are making a request to the manufacturer. Tomorrow we will send photos and video of testing to your e-mail. 30/12/2025 17:48

Mia
Good afternoon, we received the PR-15 powder dispenser in plastic vials, scheduled after lunch to open the box and test. 30/12/2025 17:58

Roman Tsibulsky
Mia, Good afternoon. Great news, please WhatsApp +79853643808 to send photo and video report. 30/12/2025 17:58

Jayden
Granulator for wet granulation ZL-25 and Mixer V-shaped for powders VM-05 under contract No. 15 inform. 30/12/2025 18:08

Roman Tsibulsky
Hello Jayden, The shipment has arrived at the customs terminal, tomorrow until 16:30 is scheduled to be transferred to the transportation company. 30/12/2025 18:11

Henry
For shipping to Monte Carlo do you have to pay anything extra ? 30/12/2025 18:18

Roman Tsibulsky
Good day Henry, In our catalog, all prices are inclusive of shipping to the customer's door. Delivery to Monte Carlo is included. 30/12/2025 18:21

Scarlett
I've been calling your office since this morning, and no one's picking up the phone. 30/12/2025 18:28

Roman Tsibulsky
Good afternoon, Scarlett! The office will be open from 9:00 GMT. We'll be in touch. 30/12/2025 18:28

James
Excuse me, I have important information, please do not deliver my shipment, automatic filling and sealing machine for glass ampoules ALG-10 to Bordeaux, but immediately upon arrival send it to Lisbon. 30/12/2025 18:38

Roman Tsibulsky
Hello James, we will try to resolve this issue for you. 30/12/2025 18:40

Grace
Good afternoon! semi-automatic liquid filling machine in barrels DF-13 , a copy of the payment is sent to the post. Start the order to work. 30/12/2025 18:48

Roman Tsibulsky
Grace, good afternoon! We have seen your payment, we receive SMS from the bank. Please send drawings of barrels and answers to our questions in correspondence. 30/12/2025 18:48

Riley
YR-90 dry and wet powder granulator YR-90 month has already passed. Hurry up the factory. 30/12/2025 18:58

Roman Tsibulsky
Riley, good afternoon. The factory has shipped your equipment to our representative, now is forming a consolidated shipment for shipment to customs. We will keep you informed. 30/12/2025 19:01