Empty vials make most sound: Empty sterile hyaluronidase vials demand quality check.

Sir,

The peribulbar block is a safer regional anesthesia technique as compared to retrobulbar block in patients scheduled for cataract surgery, especially when the block is being given by the anesthetist. We routinely add hyaluronidase to the local anesthetics used for the peribulbar blockade to improve the onset and quality of the block.[1] While preparing the drugs for peribulbar blockade recently, we encountered an empty sealed vial of injection Omnidase [Figure 1]. Product details: Injection hyaluronidase 1500 IU, sterile freeze-dried powder, Batch No. LHLDA1910, expiry date: 6/2021, available as a pack of 10 vials, manufactured by Samarth life sciences private limited, Solan, Himachal Pradesh; Marketed by Sunways (India) Private Limited, Mumbai, Maharashtra, India.

Figure 1

(a) Injection of Omnidase 1500 IU, red arrows showing empty sterile vials, yellow arrow showing “drug on stopper” defect, green arrow showing lifted lyophilized drug cake. (b) Box packaging (10 vials) of injection Omnidase as available in the market

Empty sealed sterile vials without drugs place a question mark on the quality standard of the drug manufacturing process. Sterile filtration, aseptic vial filling, lyophilization, and sealing are critical steps in the manufacture of biological products especially drugs. The final biological product/drug is usually filled in liquid form to ensure uniform subdivision and easy filling into the mouth of a narrow vial. Fill volumes must match those stated in labeling and should align with dosing regimens, not only for regulatory compliance but also for patient safety and convenience. There are three methods to ensure accurate dosing while filling the vials with liquid drugs: volumetric filling, net weight filling, and time pressure dosing. Problems that may be encountered during filling include product splash/spills, product foaming, and inaccurate dose delivery, over/underfill drug volume/weight, supply tank position/level issues, and bent, leaking, or clogged filling needles. As a part of quality assurance, all filling operations must be checked for accurate dose filling both before the start of the filling process (prefill weight) and after its completion (postfill weight). The various weight checking methods for vials include manual weight checking, single vial/whole container robotic weight checking, and noncontact weight checking. The empty hyaluronidase drug vial in our case seems to be a result of defective filling at the manufacturer level bypassing the quality checks mentioned above. Apart from empty vials, this figure also shows drugs on the stopper and lifted lyophilized drug cake which is more of cosmetic defects unrelated to drug potency/quantity.[2] We recommend strict quality check at the manufacturer level discarding overfilled/underfilled vials, provision of a drug/device website to report substandard products in the market, issue of drug alert by appropriate authorities, and recall of the entire batch of remaining vial stocks of the affected batch to the original supplier.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.