DRUG DISCOVERY AND DEVELOPMENT 49
Effective and gentle cleaning P
Nick Kristiansen reports on innovations in ultrasonic cleaning technology.
roduct contamination is believed to be the second to third largest reason
for pharmaceutical recalls in the EU. It is therefore not surprising that the EU commission recently published an update of chapters 3 (premises and equipment) and 5 (production) with a focus on minimising the risk of cross contamination.
When different pharmaceutical products are produced in shared facilities, the potential for cross contamination becomes an issue for concern. Residues of an active substance that remain after cleaning production equipment and other product contact surfaces may contaminate other medicinal products manufactured in the same facility.
Te new EU requirements under the GMP guidelines for the use of multipurpose equipment and how to minimise the risk of cross contamination have drawn more attention to this subject. Tools for the manufacturing of tablets are often used for several different products, putting this segment in the risk zone for cross contamination.
Reasons for cross contamination can be many and caused by
technical as well as organisational deficiencies. Insufficient cleaning of equipment is one of the most obvious and easiest to rectify.
Ultrasonic cleaning units provide consistent, thorough cleaning of all surfaces, which drastically reduces the risk of cross contamination.
Silent Sonic is a CE-compliant ultrasound cleaning unit that has been developed as a direct response to customers unable to find what they needed in existing cleaning solutions.
Tey needed a cleaning solution that would incorporate a user- friendly interface with easy validation execution, worker health and safety compliance, and the ability for it to be used in the smallest of laboratories.
Additionally, many organisations wished to incorporate more environmentally sustainable processes in their manufacturing.
Ultrasonic cleaning When using an ultrasonic cleaner, the object to be cleaned is submerged in a chamber containing a cleaning solution. An ultrasound-generating transducer built into the
chamber produces ultrasonic waves in the fluid by changing size in concert with an electrical signal oscillating at ultrasonic frequency, in the range from 21.5 - 100 kHz.
Te agitation produces high forces on contaminants adhering to substrates such as metals or plastics. Tis process is capable of removing impurities from the smallest holes or cavities in the subject. Cleaning normally lasts between three and 10 minutes.
Te Danish company behind the Silent Sonic, Anmasi, set out to meet the high-level sanitisation and validation requirements required by the pharmaceutical industry, and at the same time offer a cleaning solution that would fit the working environment in which personnel are present during the cleaning.
In the past, ultrasonic units on the market have exhibited a noise level that was disruptive to workers. Tis is one of the reasons why R&D departments haven’t used ultrasonic cleaning in the past.
Silent Sonic puts out 48 - 55dB(A), which is below the decibel level of normal
Fig. 1. Tablet punches before ultrasonic cleaning.
Fig. 2. Tablet punches after ultrasonic cleaning.
www.scientistlive.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120