to establish operation standard of the hot-air circulating oven to standardize the operation of the equipment so as to ensure safety and effectiveness of its use.
it is applicable to the operation of the hot-air circulating oven.
the Hot-air Circulating Oven technician and the oven operator are responsible for the implementation of this standard.
1. To check the sensitivity of the temperature meter and the cleanliness of hot-air circulation.
2. To check whether the particles meet the requirements of pharmaceutical production technology and without foreign matters.
3. Evenly spread wet particles on drying trays, with 1.5-2cm thickness on each drying tray as advisable; to feed materials onto the trays from the top down to avoid foreign matters falling into the medicine.
4. After the drying trolly is fully loaded with trays, it shall be pushed into the oven immediately for drying.
5. To operate according to the technological requirements with temperature being raised gradually from low to high, check from time to time and turn over the material as per the technological requirements to make the particle drying meet the requirements.
6. When the dried particles are cooled to or close to room temperature, take them off the trays from bottom up and put them into clean and dry buckets.
7. While barreling, please be noted that the drying trays shall be emptied to avoid loss.
8. Correctly fill the name, batch number and quantity in the form and put it into each barrel.
9. Timely and carefully fill out the original records of drying.
Ⅴ. Safety Operating Procedure
1. Check whether all parts of the oven are normal; and to see whether the valve is leaking, open the water discharge valve to discharge the water completely out of the pipe and then close the valve.
2. During use, it is forbidden to place inflammables near the oven.
3. Turn on the power supply to heat, pay attention to the temperature inside the oven, and when it rises to a temperature 5℃ lower than the preset value, the heating rate is controlled automatically. And when the temperature reaches the preset value, turn on the air blower to blast air, and the electrical system is self-controlled to make the temperature inside the oven be stable and even.
4. Check the drying condition according to the requirements of technological procedure for the product, turn over the material as required, regularly check the oven’s temperature, and strictly control the temperature as per the technological requirements.
5. Before exiting the oven, first turn off the power; then continue to blast air for a certain period of time according to the requirement of material type and turn off the air blower; at last discharge the material from the bottom up.
Purpose: to establish the maintenance procedure for the oven to prevent excessive wear and damage of the equipment so as to prolong its service life and ensure its proper functioning.
1. Do operate the equipment strictly according to the standard operating procedure during use.
2. Before using the equipment, carefully check whether all the parts are firm and whether the temperature indicator and the fans run properly, or they shall be timely replaced or maintained.
3. The operator shall check the oven before and after work: a. to make sure that the parts and the accessories are complete; b. to ensure that there is no such problems as emitting, dripping and leaking in the pipeline; c. to keep clean and greaseless without dust, rust and debris inside and outside the equipment.
4. In case of malfunctions in use, the power shall be turned off and the drying can only be started again after the equipment is repaired well.
5. The equipment shall be timely cleaned once after use and keep both the inside and the outside of the oven (including bracket and oven door) clean and greaseless without visible residues.
6. It is forbidden to place wet, corrosive or heavy items on the upper cover of the oven.
7. Usually the equipment shall be kept clean and dry, and it shall be scrubbed thoroughly once every two weeks, especially for the positions that usually are hard to clean (e.g. apertures).
8. Mainly responsible by the maintenance personnel, the oven shall be checked thoroughly every three months to repair and replace the damaged parts.
9. The oven shall be overhauled once every half year, and the maintenance of the hot-air circulating oven shall be conducted by specially designated personnel.
Purpose: to keep the equipment clean so as to ensure process sanitation.
1. Cleaning frequency: clean once after using, and clean at any time under special circumstances.
2. Cleaning tools: cleaning cloth, clean basin, rubber gloves and hair brush that are without fiber shedding.
3. Cleaning method: after use, utilize hair brush to clean both the internal and the external surfaces of the oven to remove stains.
4. Fill in the equipment cleaning records, and the QA checker shall label it “Cleaned” with a card to indicate the state after check.
5. Cleaning effect evaluation: there shall be no visible stains on the internal and the external surfaces via visual inspection.