Process of manufacturing creams and ointments:
A: Oil phrase
Add oil, wax, emulsifier and other oil solubility components into oil phrase pot and heat with agitation. Temperature should be controlled around 80℃ to 85℃. Stay warm for 15-20 minutes for sterilization after dissolving materials thoroughly. Pay attention to not over heating or long time heating in order to prevent oxidation and deterioration of materials. Oil, preservative and emulsifier which are easy to oxidize should be agitated before adding into oil phrase.
B: Water phrase
Put deionized water and other components of water phrase into water phrase pot. If water-soluble polymer in the water phrase, it would be dispersed first with propylene glycol or homogenizer with hang. Heat by agitation to 85℃ to 90℃, stay warm for 15-20 minutes.
C: Mixture with oil phrase and water phrase
Clean the vacuum emulsifying pot and evacuate condensate water, start.
a, O/W put oil phrase evenly into water phrase in the condition of agitation. Feeding speed is 5-8kg/minutes; agitation speed is 50rpm; controlled water is 75℃ to 85℃.
b, W/O put water phrase evenly into oil phrase in the condition of agitation. Feeding speed is 3-5kg/minutes; agitation speed is 50rpm; controlled water is 80℃ to 85℃.
D: Homogenizing
1, Homogenizing: start homogenizing after mixture with oil phrase and water phrase. Homogenizing time is 3-5 minutes. Usually, Small pot for homogenizing time is 3 minutes. If vacuum pump exists, it would pump vacuum, making it work under the vacuum status.
2, Agitation and emulsifying: after homogenizing, agitate under the constant warm 15-20 minutes in the 80℃-85℃. Agitation speed is 25 rpm.
E: Agitation speed control
Fast agitation speed during mixing and homogenizer, about 50rpm; Medium agitation speed during constant warm and emulsifying time, about 25rpm. Agitation speed when decreasing temperature should be slow or medium speed. Add essence , preservative and other active material when the temperature is lower than 45℃. The agitation speed at this time should be 20rpm. If vacuum pump exists, it would pump vacuum, making it work under the vacuum status. Temperature when emulsifying should be 80℃-90℃. Keep temperate above 75℃ before decreasing.
F: Above are general standard of manufacturing cream and ointments. If any particular process, it would need to combine special process with the standard process together.
Quality control points:
1, Two-phase mixing: two-phase mixing, the water phase temperature is 3℃ to 5℃ higher than the oil phase temperature, pumping to be uniform, stirring faster.
2, Stirring emulsifying: stirring emulsifying time control in 25 to 30 minutes, let it fully dispersed and emulsified.
Kos is specialized in high shear mixer for many years. Here we provide you more than machines, but solutions.
Recommended Creams & Ointments Homogenizers
Ointment Manufacturing Process – Complete Guide to Pharmaceutical Ointment Production
The ointment manufacturing process is an important pharmaceutical production method used to manufacture topical medicines for skin application. Ointments are widely used for dermatological treatments, pain relief products and medicated skin care formulations.
A well-controlled production system ensures product stability, uniformity and therapeutic effectiveness. Modern pharmaceutical facilities follow WHO-GMP guidelines to maintain quality standards throughout manufacturing.
In this guide, we explain the complete ointment manufacturing process, equipment used, quality requirements and industry best practices.
Common Types of Ointments
| Type | Application |
|---|---|
| Antibiotic Ointments | Skin infections |
| Antifungal Ointments | Fungal infections |
| Pain Relief Ointments | Muscle and joint pain |
| Steroid Ointments | Inflammatory skin conditions |
| Herbal Ointments | Natural skin care applications |
Process of manufacturing creams and ointments:
A: Oil phrase
Add oil, wax, emulsifier and other oil solubility components into oil phrase pot and heat with agitation. Temperature should be controlled around 80℃ to 85℃. Stay warm for 15-20 minutes for sterilization after dissolving materials thoroughly. Pay attention to not over heating or long time heating in order to prevent oxidation and deterioration of materials. Oil, preservative and emulsifier which are easy to oxidize should be agitated before adding into oil phrase.
B: Water phrase
Put deionized water and other components of water phrase into water phrase pot. If water-soluble polymer in the water phrase, it would be dispersed first with propylene glycol or homogenizer with hang. Heat by agitation to 85℃ to 90℃, stay warm for 15-20 minutes.
C: Mixture with oil phrase and water phrase
Clean the vacuum emulsifying pot and evacuate condensate water, start.
a, O/W put oil phrase evenly into water phrase in the condition of agitation. Feeding speed is 5-8kg/minutes; agitation speed is 50rpm; controlled water is 75℃ to 85℃.
b, W/O put water phrase evenly into oil phrase in the condition of agitation. Feeding speed is 3-5kg/minutes; agitation speed is 50rpm; controlled water is 80℃ to 85℃.
D: Homogenizing
1, Homogenizing: start homogenizing after mixture with oil phrase and water phrase. Homogenizing time is 3-5 minutes. Usually, Small pot for homogenizing time is 3 minutes. If vacuum pump exists, it would pump vacuum, making it work under the vacuum status.
2, Agitation and emulsifying: after homogenizing, agitate under the constant warm 15-20 minutes in the 80℃-85℃. Agitation speed is 25 rpm.
E: Agitation speed control
Fast agitation speed during mixing and homogenizer, about 50rpm; Medium agitation speed during constant warm and emulsifying time, about 25rpm. Agitation speed when decreasing temperature should be slow or medium speed. Add essence , preservative and other active material when the temperature is lower than 45℃. The agitation speed at this time should be 20rpm. If vacuum pump exists, it would pump vacuum, making it work under the vacuum status. Temperature when emulsifying should be 80℃-90℃. Keep temperate above 75℃ before decreasing.
F: Above are general standard of manufacturing cream and ointments. If any particular process, it would need to combine special process with the standard process together.
Quality control points:
1, Two-phase mixing: two-phase mixing, the water phase temperature is 3℃ to 5℃ higher than the oil phase temperature, pumping to be uniform, stirring faster.
2, Stirring emulsifying: stirring emulsifying time control in 25 to 30 minutes, let it fully dispersed and emulsified.
Kos is specialized in high shear mixer for many years. Here we provide you more than machines, but solutions.
Recommended Creams & Ointments Homogenizers
