Band-aids are products that we use in our daily life, and we know that Band-Aids are meant to be in direct contact with wounds, so the requirements for the production environment are also quite high. So does the production of Band-Aids require a GMP workshop? What level of workshop is needed?
Bandages are generally used in the wound location, if the product quality is not ***, for the user, not only can not bring the effect of sterilization, hemostasis and antibacterial, but also may bring the risk of wound infection. Therefore, regular band-aid manufacturers generally need to build a GMP workshop with the corresponding cleanliness level and produce in it. According to the requirements of the Detailed Rules for the Implementation of Sterile Medical Devices in Good Manufacturing Practice for Medical Devices (Trial), the exposure process area for the production of non-sterile preparations such as oral liquid and solid preparations, orifice drugs (including rectal drugs), and epidermal topical drugs, as well as the exposure process area for the final treatment of packaging materials directly in contact with drugs, shall be carried out with reference to the Class D clean area standard in the "sterile" drug appendix. That is to say, the production of band-aids needs to be produced in a clean area with a cleanliness level of D, and attention should be paid to the control of microorganisms and the corresponding sterilization procedures should be taken during production.
In the classification of clean areas in pharmaceutical factories, they are generally divided into four cleanliness levels of ABCD, Class A belongs to the high-risk operation area, Class B refers to the background area where the A-level area of high-risk operations such as aseptic preparation and filling is located, and Class C and D refer to the clean operation area with low importance in the production of sterile drugs. Class D requires that the suspended particles in the air under static conditions are greater than or equal to 05 microns per cubic meter does not exceed 3,520,000, which can be seen to be basically equivalent to the cleanliness level of 100,000 that we often say.
To sum up, the production of band-aids needs to be produced in a GMP workshop with a cleanliness level of 100,000 (D-level), which requires the workshop to not only design and construct in strict accordance with GMP procedures, but also strictly follow GMP specifications in production operations, so as to effectively ensure the production quality of band-aids.