The Parenteral Drug Association (PDA) India Chapter hosted its 2025 Annual Conference in Hyderabad in late July, drawing over 600 pharmaceutical industry experts for an engaging three-day event.
Recognised as a leading authority in container closure integrity testing (CCIT), headspace analysis, clean room contamination control, and facility maintenance solutions, we were invited by the organisers to exhibit and showcase our diverse portfolio of pharmaceutical solutions.
Throughout the event, our team engaged in in-depth technical discussions with attendees on leak testing, headspace analysis, and cleaning/facility maintenance solutions. We have compiled the most frequently asked questions from these conversations, along with our responses.
Frequently Asked Questions
Q1. According to EU Annex 1, containers sealed under vacuum must be tested for the presence of vacuum. How can this be measured accurately?
A laser head that measures moisture level in the headspace of freeze-dried (lyophilised) vials is used. The collected data is then converted into an absolute pressure reading with high accuracy using a formula.
Q2. How does the headspace oxygen acceptance limit affect machine sizing, and why is it important to set a realistic limit?
A tighter oxygen acceptance limit in the headspace increases testing time and may require additional laser heads to maintain throughput for the same container volume. This directly impacts equipment costs and space requirements. Conducting stability studies before system design is crucial to determining a realistic oxygen limit, ensuring the equipment is both effective and cost-efficient.
Q3. Why does USP <1207> advise against reusing positive samples to challenge CCIT machine results?
Microscopic leaks in positive samples can become blocked after multiple uses, leading to inaccurate results. A more reliable approach is to use an adjustable needle valve and a calibrated flowmeter to simulate leaks with controlled airflow at a set pressure. This method enables repeatable, verifiable performance checks without relying on ageing defect samples.
Q4. What are the potential drawbacks of using dummy vials to develop CCIT machine recipes?
Dummy vials, often made from solid plastic or metal, do not behave like actual production vials under vacuum or pressure. They lack the subtle “noise” present in real containers, such as minor air escape from under the crimp during the vacuum cycle or slight shape changes in plastic vials under pressure.
When recipes are created using these “silent” dummies, machines may falsely reject real vials that exhibit normal variations.
Q5. What are the most common causes of false rejects, and how can they be reduced?
Frequent causes include:
- Air pockets beneath the cap
- Moisture on the container surface
- Overly strict test acceptance criteria
- Use of unverified positive samples or dummy vials for recipe creation
Addressing these factors can significantly reduce false rejects and improve testing efficiency.
Q6. When should positive samples be used in recipe development, and what are the advantages and disadvantages?
Positive samples are useful for verifying an existing recipe but are not recommended to be used for creating a new one. Environmental exposure can alter internal pressure, resulting in inaccurate parameters.
Always test positive samples before use to ensure they are not blocked.
Q7. What causes corrosion, rouging or pitting in the production environment and can it be treated in situ?
Corrosion can result from water stains, steam, product deposits, chemical vapours, or disinfectant residues, among other causes. It often occurs not from a lack of cleaning but because ineffective cleaning tools fail to remove early deposits.
Q8. How can the risk of cross-contamination be reduced when using non-dedicated equipment?
Sahara+ cleaning tools are abrasive, provide deep cleaning, and are resistant to particulate and fibre generation. They do not scratch the cleaned surface and are effective at dislodging and removing surface contaminants from previous production batches.
Q9. How can colour build-up on equipment and surfaces be prevented when producing coloured products in OSD manufacturing?
Many facilities use smooth, low-linting polyester wipes and mops. While gentle, their minimal abrasion often makes them ineffective at removing residues, allowing deposits to build up in the troughs of surfaces. Sahara+ cleaning tools easily dislodge and remove these coloured deposits.
Q10. How can hardened films of drug product be removed without scratching equipment surfaces?
Specialised Sahara+ cleaning tools designed to dislodge and entrap surface deposits can remove residues from the metal surfaces without scratching. These are preferable to sharp implements which damage surfaces and create long-term maintenance challenges.
Q11. What is the best approach when corrosion is detected?
Immediate remediation is essential to prevent corrosion from spreading. Delaying action until a scheduled shutdown increases the risk of permanent equipment damage and contamination.
The Sahara+ remediation system offers a cleanroom-compatible solution to restore surfaces to like-new condition. When used proactively, it saves both time and cost compared with traditional chemical passivation and buffing.
Following remediation, periodic use of products such as Sahara Mops, Sahara Sponge, and MiraWIPE helps prevent recurrence by regularly removing surface deposits.
Event Highlights
Watch the highlights from the PDA India Chapter 2025 Annual Conference:
https://drive.google.com/file/d/1PXP9ZftVcF6x5bB9gBFCbLkiWMrCKONl/view?usp=sharing
Summing Up
The PDA Conference proved to be an outstanding forum for professionals to connect with industry experts, share insights, and deepen their experience in critical areas.
To learn more on Leak Testing and Cleaning/Facility Maintenance solutions visit https://groverholdings.com or call on +91 98211 11623 or write to us at vivek@groverholdings.com.
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