Solid Preparation

The Commonly Used Solid Dosage Forms Include Powder, Granule, Tablet, Capsule, Drop Pill, Film, Etc., Accounting For About 70% Of Pharmaceutical Preparations. The Common Characteristics Of Solid Preparations Are That Compared With Liquid Preparations, Solid Preparations Have Good Physical And Chemical Stability, Lower Production And Manufacturing Costs, And Are Easy To Take And Carry; The Pretreatment Of The Preparation Process Goes Through The Same Unit Operation To Ensure The Uniform Mixing And Accurate Dosage Of Drugs, And The Dosage Forms Are Closely Related; The Drug Can Be Absorbed Into The Blood Circulation Through The Physiological Membrane After Being Dissolved In The Body.

Preparation Workshop Editing And Broadcasting

General Pharmaceutical, Food, Chemical And Other Enterprises Need Granulation Production. The Granulating Machinery And Equipment Shall Be Regularly Maintained, Especially The Granulating Oven, Boiling Dryer And Wet Machine, Which Are The Main Granulating Equipment. The Mechanical Equipment Shall Not Be Operated For More Than 18 Hours Every Day, Or It Will Cause The Risk Of Ethanol Dust Explosion For a Long Time. Some Pharmaceutical Plants Need To Work In Three Shifts. It Is Recommended That Each Shift Be Controlled Within 6 Hours, And 1 Hour Of Shutdown Equipment Shall Be Reserved During Shift Change.

According To International Standards, Pharmaceutical Factories Need To Stop Production For One Quarter Each Year For Maintenance Buffer Period, And The Annual Production Should Not Exceed Nine Months. The State Food And Drug Administration Has Become More And More Strict On Drugs, Especially Tablets, Capsules And Other Drugs. Since 2020, Most Of The Drugs Will Have a Validity Period Of About One Year. Therefore, Many Pharmaceutical Factories Stop Production After Storing Drugs For The First Quarter, Which Will Not Cause Any Loss And Further Increase The Security.

In Order To Ensure Safe Production And Protect The Company's Property From Loss And Personnel From Injury, Safe Operation And Troubleshooting Of Mechanical Equipment, Air-Conditioning Circulation, Power Distribution Room, Auxiliary Machine Room, Etc. Shall Be Achieved. Pharmaceutical Companies (Factories) Must Send Personnel To Be On Duty 24 Hours a Day.

Preparation Process

In The Preparation Process Of Solid Dosage Forms, Drugs Are First Crushed And Sieved Before Being Processed Into Various Dosage Forms. If It Is Evenly Mixed With Other Components And Directly Sub Packed, The Powder Can Be Obtained; If The Uniformly Mixed Materials Are Granulated, Dried And Sub Packed, The Granules Can Be Obtained; If The Prepared Particles Are Compressed Into Shape, They Can Be Prepared Into Tablets; For Example, The Mixed Powder Or Particles Can Be Divided Into Capsules To Prepare Capsules. For Solid Preparations, The Mixing Degree, Fluidity And Filling Property Of Materials Are Very Important. For Example, Crushing, Sieving And Mixing Are The Main Unit Operations To Ensure The Content Uniformity Of Drugs. Almost All Solid Preparations Have To Go Through. The Good Fluidity And Filling Property Of Solid Materials Can Ensure The Accurate Dosage Of Products. The Addition Of Granulation Or Flow Aid Is One Of The Main Measures To Improve The Fluidity And Filling Property.

Workflow

The Weighing Post Is An Important Link In The Pharmaceutical Process. The Weighing Post Needs To Sift Raw Materials And Excipients, And Then Weigh Them Separately Or Together. Now, Most Of The Materials Are Automatically Discharged And Weighed By The Batching Machine, Saving Manpower. A Few Raw Materials And Excipients Need To Be Weighed Manually. After Weighing, They Are Placed In The Temporary Storage Room And Distributed To The Granulating Post.

Granulation Preparation Is a Very Important Link In The Production Process. In The Past, The Old Process Was Mostly Operated Manually, Which Is Very Easy To Pollute Drugs And Also Has An Impact On Human Health. Now, The National Gmp Verification Uniformly Implements The New Process, The Raw Materials Are Isolated From People, And The Automatic Granulation Production Line Is Used. The Production Conforms To International Standards, Greatly Reducing Pollution, And Significantly Improving The Drug Quality.

1. Check Whether The Weighing Post Has The Site Clearance Certificate Issued By The Qa Personnel, And Whether The Scales, Pulverizers, Vibrating Screens, Weighing Batching Machines And Appliances Used Are Clean And Complete. Only When They Meet The Requirements Can The Batching Production Be Carried Out.

2. Check Whether The Granulating Post Has The Site Clearance Certificate Issued By Qa Personnel After The Production Of The Last Batch Of Drugs, And Whether The Dryer, Wet Process, Granulator, Granulator, Mixer And Appliances Used Are Clean And Complete. Only When They Meet The Requirements Can The Granulating Operation Be Carried Out.

3. Get The Materials Produced In The Current Batch At The Weighing Position

4. Wet Mixing Of Soft Materials

5. Granulation

6. Drying In Oven Or Boiling Machine

7. Whole Grain

8. After The Total Mixing, Put The Batch Of Particles Into The Container Hopper, And Weigh And Record Them And Send Them To The Intermediate Station (Sampling And Inspection).

9. Tableting, Coating And Packaging

The Granulation Process May Determine The Quality Of Tablets (Tablet Pressing And Coating May Also Determine The Quality Of Tablets). Strictly Implement One Batch Per Shift. It Is Strictly Prohibited To Produce a Total Mixed Batch With Multiple Batches Of Materials. It Is Prohibited To Produce Different Varieties Of Drugs In The Same Line. It Is Not Allowed To Violate The Gmp Regulations, Otherwise The Gmp Certificate Will Be Returned.