In-process Checks during Primary Packaging Operations
(Blister / Strip Packing)
- Record the temperature and relative humidity of the Packaging area.
- Tablets and Capsules: Following defect /Issue to be sorted out before strip/blister sealing
- Broken Tablets
- Laminated Tablets
- Chipped Tablets
- Discoloured Tablets
- With Black particles Tablets
- With foreign particle Tablets
- Distorted Tablets
- Foil shifting: Foil shifting reduces the sealing width of strips and to be observed carefully.
- Batch coding details on foil:
- Collect the number of strips equivalent to the no. of stereos of the overprinting roller, so that strips having batch details from all the different stereos are obtained. Checks the batch details as per BPR.
- Also observe the legibility of details, missing of letters or smudging of ink.
- of Empty Pockets:
- Check each individual pocket of strip for the presence of tablet/capsule.
- Proper forming of blister:
- The blister shall be fully formed as per the shape of the cavity of forming roller. Each strip is to be carefully observed for any irregularity in the shape of blisters.
- Proper cutting of the strips:
- Examine the strips for proper cutting by measuring the sealing width on opposite sides of strips and also observed any displacement of printed matter. Ideally the sealing width on the opposite sides of the strip should be equal.
- Appearance of the strip: Check the strips
- For poor knurling,
- hologram creasing on foil and
- Faulty printing such as ink lining; ink patches and poor legibility of printed letters.
- Strip size:
- Measure the length and width of strip and verify the results with the values given in packaging technical directions.
- Leak test: perform leak test as per the approved procedure.
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube