Our proposition : Information

Information is a valuable asset and critical to every process. Information management, planning and availability are dependent on technology, processes and people. Informed decisions are made by people with data, people who understand data and mine the data for specific information that drives action and increases speed!

Incremental pieces of data exist with individuals and departments within organisations. Sometimes external information regarding equipment, technology and regulatory updates is not percolated through the organization. ViennI works with teams within the organization and brings in external information to get to the solution. We routinely adviseorganizations on how to effectively use their information to advance decision-making, improve operational efficiency and deliver outcomes. We engage with stakeholders, identify requirements and provide genuine answers to real problems.

We assist clients by managing the complete process life cycle from needs analysis and requirements to evaluation, integration and deployment. This process is highly information driven.

Quite often pharma production units, companies, approach ViennI for help with their processes. In many cases, the QA, QC and lab and production teams are doing “routine” functions. Yet, the regulatory requirements are not met, there are sterility issues and the situation quickly becomes un-resolvable. The execution of a solution in such cases is always starts with an extensive exercise in data analysis, mining for useful information.This information is cross checked with industry standards and regulatory expectations and LO AND BEHOLD………we see results!

ViennI uses “Information”  as an asset to advance your cause. Get in touch at vienni.india@gmail.com

The A , The B , The C , The D and The E of a successful workshop

Training programs often give participants a better understanding of why the "Topic of Training" is essential in the work environment. Most often you leave feeling more knowledgeable, buoyed and hopeful for the future, but when you return to your desk, you will often find that you are back to square one. Too often training inspires and captivates, but it doesn't teach micro-behavioral skills that are fundamental to achieving real transformation

We work in a world where organizations operate as networks of projects and teams work across a matrix as opposed to a hierarchy. In the realities of today’s production, QC and QA environments, everyone will have to lead from the front, take ownership and for that they must have tools necessary to start.

That's why QA, QC, Sterilization training should zero in on specific micro-behavioral skills people will need to work across silos and with teams. It needs to provide tools participants can use to make decisions, solve problems, avoid issues and achieve regulatory success. Only when knowledge, operations, attitudes and skills are broken down to a series of micro skills will training be able to be aligned with the organizational objectives.

Here are five essential elements that should help one hone in on the right training program for the organization:

Applications -> Applicability ->Adaption:
We all learn the science/technology in college; We all know what the applications are. It takes a workshop like the HBOS to actually experience the “Eureka” moment! The moment where you relearn the application and instantly realize that it can be directly be applied at site of work. The sharing of experiences and the best practices in addition encourages and ensures adaption. A book, a website, a document and a seminar will only give us the applications. A truly well designed workshop will give us

Applications -> Applicability -> Adaption and that’s what our participants said!

“ The knowledge gained in this workshop will help in solving routine problems at work in a better         manner.”

“The program was excellent. Learnt about load orientation, QBD,QBR and Data Integrity. Also        learnt new concepts in autoclave. Got better understanding with concepts of D-value, Z value."
                                                                                                             

Benefits, Basics
Perhaps the above point applies only to a few people. For quite a few of us a revisit to the basics is a good idea. Sometimes knowledge is lost in the rigor of routine. Taking time off from our daily rigmarole to re-learn the basics has distinct advantages. Come and participate in a program that strengthens your fundamentals. Revisit the basics with us. Here are a few participants who did and this is what they had to say…..

“Basics were revised again. Data integrity session was really good.”
                                                                                                       
“Very good program. Got basic knowledge of sterilization.”  
                                                                                               

Content, Content, Content
In a 2 or a 3 day workshop, training or learning program, how much can we absorb? Quite a bit at the end of the program, but the retention of this learning is fully dependant on the quality of the content. The stronger the content, greater the retention.  At Vi’eNnI, course/workshop content is developed while respecting this fact. Each slide, case-study, problem, issue is thoroughly evaluated for the richness and utility. Constant updation and improvisation is done on the material. It is also a stark reminder that “Content” indeed is the king! It is our constant endeavour to keep our content, current and relevant. It shows in some of the feedback received like

“Content was good and speakers delivered it well….”
                                                                                
 “Content was really good. …………….All the concerns and all the departments were got together        and different issues of different departments were covered.”
                                                                                                 
Delivery, Delivery, Delivery
In a workshop attended by 30 people, typically we get 5 kinds of criticisms:
1. You spent way too much time on………….
2. Way too little time was spent on….
3. More cases, problems, theory, examples …..
4. I thought this was an advanced course, not a basic course!
5. Some topics were too advanced, can we have some pre-course reading?
Once in a while we see them too and that’s when we get the opportunity to improve on our success.

Engagement
This is the final cog in the wheel. We at Vi’eNnI endeavour to continue to engage with our participants and clients to continuously evolve our programs to make them more specific and targeted. More need based and real
We seek your suggestions and feedback and execute on your requirements. We wish to initiate more conversations on your learning needs and tailor make programs for you. For starters, join the conversation at “ LINKEDIN GROUP” and tell us what you would like to see in our future programs, in terms of content and delivery. Add your comment to the blog here. Or just email us at vienni.india@gmail.com or call us at 080 23506562

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. 

Whispering Microbes and Talking Inspectors

Companies and professionals working in the QC, QA departments of the pharma industry are increasingly facing the need to constantly update themselves and their teams on the various regulatory requirements, technologies and techniques. This need arises from the desire to maintain leadership, the requirement to comply with regulations and the most importantly to meet the quality expectations.

The workshop ”Whispering Microbes and Talking Inspectors " was held in Hyderabad on 5^th and 6^th of June 2014. It was organized by Vienni training and consulting LLP. The workshop aimed at introducing and educating pharma professionals on how to better manage and control microbiological issues. The main theme of the workshop was a review of the misconceptions, chief expectations and monitoring requirements of an environment monitoring program and data integrity, considering not only the impact brought by the advances in the technical dimension, but also other dimensions such as policy, quality, regulatory and technical aspects.

The workshop was opened to only 27 selected participants, representing 9 companies from across the country via systematic selection process.

The workshop was inaugurated by a thought-provoking discussions on the most common misconceptions that professionals have while they design an EMP. The workshop took off in the right earnest, with a presentation on the handling of microbiological data deviations. A very engaging case study served as a bridge between the two presentations and kept the participants keenly focused on the subject at hand.

A subsequent presentation on “Assessing Integrity of Microbiological Data: In-spector’s expectations and how to reach compliance” provided serious inputs to enable better assessment. Discussions after the talk showed the increased understanding that the participants gained. Most feedback suggested that the participants were now better equipped to evaluate data and certainly were better at understanding inspectors expectations.

The workshop continued on Day 2 with a discussion on “Performing self inspections of microbiology laboratory: Tricks and Traps”. Scaling up operations is always needs a great deal of experience and the very next topic was “Laboratory Sterilization - Cycle design and qualification: Operational differences between laboratory and production sterilization “. And the day two ended with a talk on Designing of Microbiological tests for complex formulations.

 At the conclusion of the workshop there was a general agreement that the event was a perfect fit for the professionals’ training needs. Given the increased use of technologies, need for regulatory compliance and the rush to the market, there was a request from all participants to continue to organize more such workshops. Finally, it was proposed to establish an open forum under the Vienni umbrella, to continue the discussion and the exchange of ideas. In that spirit, a linked-in group has been started for the participants.

Dry Heat Sterilization Cycle Design & Development at lower temperature

There are standards and references available for people wanting to establish dry heat sterilization cycles at lower temperature. While these standards help in learning, it is indeed a challenge when you are asked to establish dry-heat sterilization process for steroidal API.

This is the story of a project of VIENNI™. The project started like others with initial trials conducted by the client’s in-house validation team. The results were not satisfactory. The challenge persisted while a few facts were overlooked. The product, process and procedures needed an expert’s touch!

The basic challenges:

1.   Product safety and efficacy has to be retained

2.  Development of an effective sterilization cycle recipe

3. Presentation of microbiological results

Vienni was brought-in to support for design and to develop the dry-heat sterilization cycle. The initial gap analysis revealed some interesting facts in the sterilization cycle design process. The most important gaps identified were taken stock of and assessed through discussions. Some of them are as listed below:

      1. Arrangement pattern of containers used to keep load item (The API)

            2.  Use of non-uniform perforated containers
      3.   Location of the containers
      4.  Packing of the load item (the API)
      5.  Cycle parameter establishment
      6.   Product stability at the stated temperature
      7. Temperature profile

The above gaps were systematically addressed and closed. The new process and parameters determined were implemented.

The very first step in the implementation was to address the arrangement pattern of containers, uniform perforated containers, arrangement and location of the containers, optimized packing of the load item, hence, first four challenges were overcome! The next step was to set the physical parameters of the cycle. These parameters were found to be inconsistent and performing above the limit, during initial trials and were identified to be a recurring problem. The Eureka-moment was when the temperature in the load items was reduced to below the temperature recorded during initial trials and the set parameters were revised accordingly. Finally, after a few science-and data-based trials, the temperature inside the product was recorded within the limits.

The last challenge was to prove acceptance through the microbiological studies i.e. BI-incubation and the sterility test. The results of the microbiological studies results were also found as per the pre-determined specifications. A trial run was conducted to evaluate and establish the come-up time, which was found to be insufficient after which some more trials were required to determine the optimum come up time, sterile hold and cool down time. The runs passed the sterility test and the incubation test in flying colours.

The exposure time and temperature of the cycle was set based on the D-value calculation of the biological indicator.

Experience, expertise, rigor and patience helped us establish, develop and design a dry-heat sterilization cycle in a record time. Yet another feather in our cap!