Picture the scene: Unprecedented rainfall and poor flood defences causes flooding to a biopharmaceutical facility, damaging equipment, making large areas of a site unsafe and inaccessible, and preventing staff from even making it into work. Product batches can be lost and new production delayed while the facility gets up and running again, with the resulting impact on the supply of essential drugs.
This is a very real problem. In the summer of 2017, for instance, a major cold packaging and distribution facility for the pharma industry was hit by a power cut due to a severe storm in Pennsylvania, resulting in products being quarantined. In 2016, a biotech firm in New Jersey suffered damage to its manufacturing capability when a malfunctioning sprinkler system caused the site’s clean room to be covered in stagnant water and silt.
There are numerous scenarios and incidents that can unexpectedly occur and have a serious impact on a biopharmaceutical company’s ability to operate, such as those detailed above, as well as:
- Wind damage and lightning strikes
- Explosions and fire
- Criminal acts including theft, cyber attacks and sabotage
- Power loss
- Human error
- Mechanical breakdown
- Loss of staff (for instance due to a viral outbreak)
This blog presents the steps involved in building a business recovery plan and key factors to consider.
When disaster strikes, do you have a plan?
As vendors and end-user supply chains become ever more closely integrated, it’s therefore vital that these risks are understood and that organisations have plans in place to mitigate them. Business recovery planning – or disaster recovery planning – is a key part of that process. In every scenario, it’s prudent to assume that a catastrophic incident will occur at the worst possible time – for instance when a fire breaks out during a shift swap over when there are twice as many people on a site and in different stages of logging in and logging out. An effective business continuity plan should have a procedure to assess, review, relocate (if necessary) and recover to ensure that downtime is minimized.
The first step in building a robust business continuity plan is to have a policy in place to look at the risks and create a mitigation strategy. This should include clear objectives and defined roles and responsibilities for staff.
An example is as follows:
- Maintain essential customer services to sustain the confidence of customers, vendors, employees and shareholders.
- Provide the re-establishment of critical operations within 48 hours of a declared disaster in the defined priority sequence.
- Provide for the restoration of all operations within seven days.
- Achieve the above in a cost-effective manner.
When looking at disaster scenarios, organisations should consider the effect on a facility should the worst case scenario occur, as well as the impact on the workforce, such as their access to the site. They should also consider appropriate evacuation procedures for each scenario, and support procedures for staff — taking into account funds, housing and transport.
Key factors to consider when creating a business recovery plan
Equipment which is critical to your operations should be identified and a plan should be put in place to repair, replace and/or rebuild the equipment, based on the characteristics of the equipment in question. To do this, determine if the equipment is unique, rare or commonly available. Blueprints and schematics of the equipment should be securely stored, and manufacturers should also identify where they could source alternative equipment, such as through outsourcing, leasing or borrowing equipment from other sites.
Biopharmaceutical manufacturers should have a plan in place for the loss of critical utilities: electrical power, gas supply, water and compressed air. The plan should ensure that in the event of a disruption to access to one of these services, the required utilities are brought back online with minimal disruption to critical processes. For instance, if water services are lost or reduced, the supply of water should be limited to essential services, and a plan should include the provision of tankers to supply the site.
Similarly, backup generators, rented from approved vendors, should be considered when examining the risks posed by the loss of electrical power and compressed air, while a backup gas supply – drawn from cylinders or a tanker – could help to reduce the impact of a loss in gas services. In all cases, reducing demand for utilities – and prioritising essential services – should be part of the risk mitigation strategy.
The supply chain
Business continuity planning should also put the supply chain in sharp focus. Supply chain risks can be mitigated by stock levels that match usage rates and allow for known build times. It’s also vital to ensure that suppliers are qualified and have robust business continuity plans in place. Dual sourcing is an important risk mitigation policy and some vendors will offer dual manufacturing of consumables to enable this.
Finally, regular drills – designed specifically for each scenario, such as fire evacuation – are an important part of the preparation process. Should a plan need to be executed, staff must know their roles and responsibilities – and how to carry these out.
In conclusion, by identifying and understanding the risk, and establishing processes and procedures to overcome the effects of a potentially catastrophic incident or threat to production, biopharmaceutical manufacturers can ensure that damage to their operations is limited, with the resulting benefits for their businesses, and ultimately, patients.
What process protection measures do you have in place? Let us know in the comments below.
This post was contributed by Guy Matthews, market development manager, Parker Bioscience Division, United Kingdom.
Parker Bioscience Division specializes in automating and controlling single-use processes. By integrating sensory and automation technology, a manufacturer can control the fluid more effectively, ensuring the quality of the final product.