We have a keen “EYE” for API’s to be used in Ophthalmic Formulations!

DHS-Cycle design and development using different Biological Indicators

APIs used in the pharmaceutical industry are generally non-sterile. It is however essential to use sterile APIs to manufacture a sterile product.

An ophthalmic parenteral manufacturer intended to use a dry powdered steroidal API in the formulation of a sterile product. This steroidal API had a bio-burden of 100 CFU/gm. Options considered although were plenty, we had to narrow our choice to a sterilization process in a DHS. Heat exposure studies at the labs depicted that temperatures < 115⁰C was safe, while there was a risk of product degradation at temperatures >115⁰C.

Our study began in earnest to design a sterilization cycle with trials, to achieve the desired results. A series of trials and constant monitoring of the temperature profile helped us determine a matrix of parameters for sterilization. Trials were conducted using Bacillus atrophaeus as a biological indicator. The exposed BIs were subjected to microbiological evaluation where maximum of a 3-Log reduction was recorded. The sterility test trials were clearly found to be meeting specification, however the minimum Sterility Assurance Level expected for the process was  6 log  !

Sticky situation indeed! The trials although were meeting the sterility test specs in flying colours yet were falling short of the expectations when it came to log reduction. A thorough investigation of the process and the testing strategy was undertaken. An elaborate analysis and an organised ‘detective ‘work led us to the issue! A repeat of the study subsequent to problem identification provided results, those that were amazing yet expected a 6-log reduction finally! Two more trials were conducted to confirm the physical parameters and microbiological tests and the results were bang on!

A happy customer, a robust process, great experiments and yet another feather in our cap. If your process needs similar intervention, our technical spirits aren't doused yet and we await your ‘call’ to get nose-deep into tricky situations.

Reach us to reach you at 080-23506562 or write to us at vienni.india@gmail.com 

Our Proposiotion : Value

Last week we posted on the 6 vital elements that a consultant brings to the table. It might be worthwhile to explore each in greater detail. The first element discussed was “Value”.

How do you measure the value gained by a consulting engagement?

To achieve consulting results consistently and reliably you have to measure, monitor and manage the successes being achieved at all stages of the process.
Ideally, every consulting project should have measurable outputs. We at VieNnI are acutely aware that, we need to be able to demonstrate value, not simply promise it.
We see ourselves as generating three different types of value:
• Value from effectiveness: We use it when the inputs into a project are uncertain but the output can be measured. Quite often, in our experience, multiple yet apparently disconnected inputs come flowing in, but one thing that the customer is certain about, is the out-put. A 40% increase in yield, decrease in contamination, successful audit, confidence in error management etc. And we always measure up to the challenge.
• Value from efficiency: This happens when the output of a project remains uncertain, but where the work carried out by us can be measured. It is typically about getting things done faster, with lesser resources, perhaps preparation for the inspection, make sure that N batches are produced in specific period, process optimization, turnaround time etc.
• Value from economy: When we simply undertake or make routine technical tasks/processes less expensive, there is value for economy and this is the easiest to measure! We always come up with solutions that are less expensive to execute, cost effective and give a great Return on Investment (RoI)

For all of us at ViennI, the rules are simple: The criteria set for success should be shared by as many stakeholders as possible. It is the medium-term, practical impact of a project that matters, not it’s short-term ‘wow’ factor. The most important thing, is getting results – if these can be demonstrated, as effectiveness, efficiency or cost…….you can measure the “Value”. When you seek to build in tactical elements rather than engaging with just strategic inputs you can be certain we walk the entire distance.  Reach us to reach you at 080 – 23506562 or vienni.india@gmail.com

Should you need Consulting Services

Can processes be more efficient? Can SOPs be more reliable? Can inspections be smooth? Can one ensure continual improvement in every aspect of the lab and manufacturing floor?

The answer…….A RESOUNDING YES !

True, organization leaders, technocrats and scientists can help, but sometimes an outside perspective can help. It is not only when one faces difficulties or hurdles that a consultant would be needed. Here is why a consultant can always help:

• Value: Internal staff how much ever qualified needs to mount extra effort when they already encumbered with a full workload, when faced with hurdles. A consultant is able to devote full attention to the problem or task assigned, solve the problem in time to the full satisfaction of the firm’s requirements. Value for ones investment indeed!
• Information: Consultants build a bias for action and increase the speed with which results are achieved. They often are the MOST informed people and are ready with loads of data to direct ones actions in specific and result-oriented directions.
• Experience: To bring special skills to own. Some tasks really do require a specialist. Consultants typically become consultants after years of working in the field. They are more experienced both in terms of the years of work and the diversity of work. 
• Novelty: A consultant brings a fresh, unbiased view to the situation or need, something those close to a situation may have difficulty achieving. Novel approaches to problem solving are a consultant’ forte.
• Network: Consultants by the very nature of the work done are the MOST networked professionals. Should a need arise to bring in extra resources, capabilities or systems; they would be able to suggest and help one to deploy with speed and efficiency. 
• Innovation:Internal teams sometimes need an external prodding to innovate. Consultants can bring in the spirit of innovation and nurture internal teams to think outside the box. 

Connect with us and talk to us at vienni.india@gmail.com . Our strengths can be yours and together any hurdle can be crossed!

Regulatory and Business impact of Equilibration Time (ET)

Sometime back a sterile manufacturing firm was audited and the regulators found deviations in the ET standard limits for different loads.

All of us are aware that ET is the “period which elapses between the attainment of the sterilization temperature at the reference measuring point and the attainment of the sterilization temperature at all points within the sterilization load” EN ISO 17665-1:2006.

It was very important for the firm to meet the ET standard limits to make sure the following were achieved-

To achieve the same the firm decided to replace the autoclave that was 7-years old as a corrective step subsequent to an internal meeting.

While the team started discussing with autoclave suppliers and manufacturers they faced the dilemma of tackling challenges with changes and alteration.

Seeking alternates to replacements team Vienni^TM undertook a gap audit, gap assessment and analysis and provided solutions for optimization with revised cycle parameter yielding firm phenomenal savings of a variety.

Team Vienni^TM took 4 working days to execute this project, ranging from helping the firm to optimize resources which was a permanent solution.

Three successful validation runs were conducted and all met the acceptance criteria for critical parameters including ET.

Now, the firm continues to successfully manufacture the batches without any regulatory hurdle of Equilibration Time.